FDA Adverse Event
Injury
Summary report: N
SUMMIT DUOFIX TAP SZ5 HI OFF
MDR report key: 1000098
·
Received February 18, 2008
Report
- Report Number
- 1818910-2008-00554
- Event Type
- Injury
- Date Received
- February 18, 2008
- Date of Event
- October 1, 2007
- Report Date
- January 28, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- JDI
- PMA / PMN Number
- P040023/R012
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, 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 CONTRIBUTION TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.
Description of Event or Problem · 1
CLINICAL REPORT STATES, THE PATIENT WAS REVISED BECAUSE OF A PERIPROSTHETIC FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUMMIT DUOFIX TAP SZ5 HI OFF | 87JDI | JDI | DEPUY ORTHOPAEDICS, INC. | NA | BG7BX1000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |