FDA Adverse Event
Injury
Summary report: N
NEUFLEX PIP IMPLANT SZ 1
MDR report key: 1609197
·
Received February 12, 2010
Report
- Report Number
- 1818910-2010-00652
- Event Type
- Injury
- Date Received
- February 12, 2010
- Date of Event
- January 15, 2010
- Report Date
- January 15, 2010
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- KYJ
- PMA / PMN Number
- K083107
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
PATIENT WAS REVISED TO ADDRESS A FRACTURE OF THE DORSAL CORTEX OF PHALANGE WHICH OCCURRED DURING ORIGINAL SURGERY AND DID NOT HEAL. THE DEFECT WAS GRAFTED AND THE LOOSE PIP IMPLANT WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEUFLEX PIP IMPLANT SZ 1 | 87KYJ | KYJ | DEPUY ORTHOPAEDICS, INC. | NA | C3BJB1000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |