FDA Adverse Event
Injury
Summary report: N
CROSSLINK ANCHOR PG GLENOID 44
MDR report key: 4232308
·
Received November 6, 2014
Report
- Report Number
- 1818910-2014-31310
- Event Type
- Injury
- Date Received
- November 6, 2014
- Date of Event
- October 14, 2014
- Report Date
- October 14, 2014
- Manufacturer
- 1818910 DEPUY ORTHOPAEDICS, INC.
- Product Code
- KWS
- PMA / PMN Number
- PK052472
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY..
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).
Description of Event or Problem · 1
PATIENT WAS REVISED TO ADDRESS PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 712847 | CROSSLINK ANCHOR PG GLENOID 44 | SHOULDER BEARING | KWS | 1818910 DEPUY ORTHOPAEDICS, INC. | 428755 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |