FDA Adverse Event
Injury
Summary report: N
NI
MDR report key: 1932918
·
Received December 14, 2010
Report
- Report Number
- 2520274-2010-00245
- Event Type
- Injury
- Date Received
- December 14, 2010
- Report Date
- November 18, 2010
- Manufacturer
- SYNTHES (USA)
- Product Code
- HRS
- PMA / PMN Number
- NI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. MANUFACTURE SITE AND MANUFACTURE DATE CANNOT BE DETERMINED WITHOUT A LOT NUMBER. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.
Description of Event or Problem · 1
ATTORNEY ADVISED THE PATIENT FELL SUSTAINING A COMPLEX, COMMINUTED INTRAARTICULAR DISTAL TIBIA AND FIBULA FRACTURE WITH MORTISE DISRUPTION AND WAS IMPLANTED WITH A LOCKING COMPRESSION PLATE. PATIENT CONTINUED TO HAVE PAIN AND THE HARDWARE WAS REMOVED. IT WAS DISCOVERED ON REMOVAL THAT THERE WAS AN UNKNOWN FAILURE OF THE HARDWARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NI | NI | HRS | SYNTHES (USA) | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |