FDA Adverse Event
Injury
Summary report: N
HARD TISSUE REPLACEMENT
MDR report key: 2389980
·
Received December 28, 2011
Report
- Report Number
- 0001032347-2011-00141
- Event Type
- Injury
- Date Received
- December 28, 2011
- Report Date
- December 12, 2011
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- KKY
- PMA / PMN Number
- PK924935
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON REVIEWING LITERATURE ARTICLES FOR POST MARKET SURVEILLANCE, A JOURNAL ARTICLE WAS REVIEWED THAT REPORTED COMPLICATIONS OF IMPLANTING HTR PRODUCTS. SINCE THE PATIENT AND PART NUMBER IS UNKNOWN, IT IS UNKNOWN IF THE REPORT WAS PREVIOUSLY REPORTED TO BIOMET MICROFIXATION, OR IF AN MDR WAS PREVIOUSLY FILED. THE PACKAGE INSERT STATES THIS TYPE OF EVENT MAY OCCUR. IF ANY ADDITIONAL INFORMATION IS RECEIVED THAT ADDS CONTENT THAT IS RELEVANT TO THIS REPORT, A FOLLOW UP REPORT WILL BE SENT.
Description of Event or Problem · 1
A REVIEW OF JOURNAL ARTICLES STATES THERE WERE 5 CASES OF COMPLICATIONS IN HTR SURGERIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARD TISSUE REPLACEMENT | HARD TISSUE REPLACEMENT | KKY | BIOMET MICROFIXATION | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |