FDA Adverse Event
Injury
Summary report: N
SOL SYS 10.5 MMA 6IN
MDR report key: 1053333
·
Received May 22, 2008
Report
- Report Number
- 1818910-2008-01980
- Event Type
- Injury
- Date Received
- May 22, 2008
- Report Date
- May 6, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- LPH
- PMA / PMN Number
- K953703
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODE SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.
Description of Event or Problem · 1
THE PT IS HAVING PAIN, X-RAY CONFIRMED FRACTURE DEVICE. NO REVISION SCHEDULED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOL SYS 10.5 MMA 6IN | 87LPH | LPH | DEPUY ORTHOPAEDICS, INC. | NA | S4JA71007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |