FDA Adverse Event
Injury
Summary report: N
PINS/WIRES
MDR report key: 2572762
·
Received May 3, 2012
Report
- Report Number
- 2520274-2012-00737
- Event Type
- Injury
- Date Received
- May 3, 2012
- Report Date
- April 9, 2012
- Manufacturer
- SYNTHES USA
- Product Code
- DZK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.
Description of Event or Problem · 1
A PT WAS TESTED ON AN UNK DATE FOR AN ACROMION FRACTURE WITH TENSION WIRES AND SCREWS. SUBSEQUENTLY, THE PT RETURNED TO THE SURGEON COMPLAINING OF PAIN. EXAMINATION AND X-RAYS REVEALED A NON-UNION OF THE ACROMION. THE PT WAS RETURNED TO THE OPERATING ROOM FOR REMOVAL OF ALL HARDWARE, WHICH WAS REPORTEDLY INTACT. THE PT WAS REVISED TO TWO (2) 2.7MM LOCKING COMPRESSION PLATES AND SCREWS. THIS REPORT IS #3 OF 3 FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PINS/WIRES | PINS/WIRES | DZK | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention |