FDA Adverse Event
Injury
Summary report: N
3.5MM CANNULATED LOCKING SCREW
MDR report key: 10514030
·
Received September 10, 2020
Report
- Report Number
- 3006460162-2020-00099
- Event Type
- Injury
- Date Received
- September 10, 2020
- Manufacturer
- ORTHOPEDIATRICS, CORP
- Product Code
- HWC
- PMA / PMN Number
- K111086
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ORTHOPEDIATRICS FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REFERENCE (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED A LOOSENING OF A CANNULATED LOCKING SCREW INSIDE A DFOS PLATE. THE SCREW WAS BOTHERING THE PATIENT, SO THE SURGEON TOOK THE 3 DISTAL SCREWS OUT. ALL OF THEM SHOWED SIGNS OF METALLOSIS AND YOU COULD SEE CLEAR SIGNS OF DEBRIS. THE PATIENT RECEIVED 2 SCREWS (ON REQUEST OF THE MOTHER), THE SURGEON INSISTED ON KEEPING ONE FOR THE COMPANY FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 978216 | 3.5MM CANNULATED LOCKING SCREW | BONE SCREW | HWC | ORTHOPEDIATRICS, CORP | 00-0907-3750 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | 3.5MM CANNULATED LOCKING SCREW PART # 00-0907-3750| 3.5MM CANNULATED LOCKING SCREW PART # 00-0907-3750| DISTAL FEMORAL OSTEOTOMY PLATE (DFOS) |