FDA Adverse Event
Other
Summary report: N
WRIST ARTHRODESIS NAIL SYSTEM
MDR report key: 2345380
·
Received November 14, 2011
Report
- Report Number
- 3006742481-2011-00002
- Event Type
- Other
- Date Received
- November 14, 2011
- Date of Event
- July 29, 2011
- Report Date
- November 15, 2011
- Manufacturer
- SKELETAL DYNAMICS LLC
- Product Code
- HSB
- PMA / PMN Number
- K092720
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SYSTEM COMPONENTS EXPLANTED: CATALOGUE: IMP-DRN-LNG, LOT#: AZ0710011, MFG DATE: 10/20/2010; IMP-WC-0207, AZ0710016, 10/19/2010. PHYSICIAN INDICATED THAT DEVICE APPEARED TO HAVE FUNCTIONED AS EXPECTED, AND CAUSE FOR EXPLANTATION WAS PATIENT RELATED. REVIEW OF MANUFACTURING RECORDS DEMONSTRATE THAT ALL MATERIALS MET ANTICIPATED RELEASE CRITERIA AND NO ANOMALIES WERE NOTED. (B)(4).
Description of Event or Problem · 1
A WRIST ARTHRODESIS IMPLANT WAS EXPLANTED FROM A PATIENT DURING A SURGICAL PROCEDURE DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WRIST ARTHRODESIS NAIL SYSTEM | NONE | HSB | SKELETAL DYNAMICS LLC | REFER TO NARRATIVE | AZ0322002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Required Intervention |