FDA Adverse Event
Injury
Summary report: N
ADVANTIM(R) TIBIAL SELF-TAP. CANCELLOUS BONE SCREW
MDR report key: 6004460
·
Received October 6, 2016
Report
- Report Number
- 3010536692-2016-01273
- Event Type
- Injury
- Date Received
- October 6, 2016
- Date of Event
- August 29, 2016
- Report Date
- September 6, 2016
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Description of Event or Problem · 1
ALLEGEDLY PRIMARY SURGERY WAS (B)(6) 2016. THE SURGEON FOUND THAT THERE WERE CUP DISLOCATION AND SCREW BREAKAGE. SO THE SURGEON PERFORMED REVISION SURGEON AT (B)(6)2016. SURGEON'S OBSERVATION IN THE SURGERY THAT THERE WAS LIKE METALLOSIS BECAUSE THE NECK AND THE TISSUE CHANGES TO BLACK. THE PARTS ARE NOT CONSIGNMENT PARTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654677 | ADVANTIM(R) TIBIAL SELF-TAP. CANCELLOUS BONE SCREW | KNEE COMPONENT | HWC | MICROPORT ORTHOPEDICS INC. | 1430371 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |