FDA Adverse Event
Malfunction
Summary report: N
ORTHOPEDIATRICS 4.5MM PLEO OSTEOTOMY GUIDE
MDR report key: 2804292
·
Received October 19, 2012
Report
- Report Number
- 3006460162-2012-00006
- Event Type
- Malfunction
- Date Received
- October 19, 2012
- Report Date
- September 23, 2012
- Manufacturer
- ORTHOPEDIATRICS CORP
- Product Code
- HRS
- PMA / PMN Number
- K083286
- Removal / Correction Number
- 300640162-10-18-2012-003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
CLASS I GENERAL SURGICAL INSTRUMENT, 4.5MM PLEO OSTEOTOMY GUIDE (COMMON NAME DRILL GUIDE), WAS MANUFACTURED WITH DEFECTIVE THREADS AND DOES NOT MEET DESIGN SPECIFICATION OR MEET INTENDED USE. NO ADVERSE EVENT REPORTED. ADDITIONAL INFORMATION - CATALOG # 01-1050-0067 AND LOT # 7861101.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHOPEDIATRICS 4.5MM PLEO OSTEOTOMY GUIDE | DRILL GUIDE | HRS | ORTHOPEDIATRICS CORP | NA | 7861001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |