FDA Adverse Event
Other
Summary report: N
ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PL
MDR report key: 3522804
·
Received September 27, 2013
Report
- Report Number
- 3006460162-2013-00012
- Event Type
- Other
- Date Received
- September 27, 2013
- Report Date
- September 17, 2013
- Manufacturer
- ORTHOPEDIATRICS CORP
- Product Code
- HWC
- Removal / Correction Number
- 3006460162-09-25-2013-00
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CAPA (B)(4) HAS BEEN INITIATED TO EVALUATE PROBLEM/ROOT CAUSE AND CORRECTIVE ACTION. ENTIRE LOT HAS BEEN RECALLED. RECALL #3006460162-09-25-2013-003-R.
Description of Event or Problem · 1
SALES REP DISCOVERED RECEIPT OF MISLABELED BONE SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 491209 | ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PL | SCREW, BONE FIXATION | HWC | ORTHOPEDIATRICS CORP | 009U2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |