FDA Adverse Event
Injury
Summary report: N
AEQUALIS REVERSED
MDR report key: 4638147
·
Received March 24, 2015
Report
- Report Number
- 9610667-2015-00012
- Event Type
- Injury
- Date Received
- March 24, 2015
- Report Date
- March 2, 2015
- Manufacturer
- TORNIER SAS
- Product Code
- KWS
- PMA / PMN Number
- K030941
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(6). RISK FACTORS FOR PERIPROSTHETIC INFECTION AFTER REVERSE SHOULDER ARTHROPLASTY. JOURNAL OF SHOULDER ELBOW SURGERY, 24 (2): 161-166. THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.
Description of Event or Problem · 1
NINE PATIENTS DEVELOPED A LATER OR CHRONIC INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 197679 | AEQUALIS REVERSED | UNK | KWS | TORNIER SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |