MAUDE manufacturer profile
SYNTHES ELMIRA · HRS
MAUDE profile for Plate, Fixation, Bone
Key facts
| Manufacturer | SYNTHES ELMIRA |
|---|---|
| Manufacturer group | SYNTHES ELMIRA |
| Product code | HRS |
| Product code name | Plate, Fixation, Bone |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Break, Adverse Event Without Identified Device or Use Problem, Failure of Implant, Nonunion/Delayed-union Bone Fracture, No Code Available, Pain, No Known Impact Or Consequence To Patient, Impaired Healing Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1