FDA Adverse Event
Injury
Summary report: N
ROUND CALCAR PUNCH MEDIUM
MDR report key: 9126011
·
Received September 26, 2019
Report
- Report Number
- 3010536692-2019-01056
- Event Type
- Injury
- Date Received
- September 26, 2019
- Date of Event
- August 8, 2019
- Report Date
- January 14, 2020
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- HWP
- UDI-DI
- M684200700531
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PLEASE VOID THIS REPORT. ADDITIONAL INFORMATION RECEIVED BY REPORTER REVEALS THAT THIS IS A NON-REPORTABLE INCIDENT. NO SERIOUS INJURY OCCURRED IN THIS INCIDENT.
Additional Manufacturer Narrative · 1
THIS EVENT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
ALLEGEDLY, UNIVERSAL HANDLE: BREAKING OF THE TEETH CONJUNCTION BROACH TIP. ZELPI RETRACTORS: THE SELF RETAINING TEETH DOESN'T KEEP THE POSITION. ROUND CALCARS: BREAKING OF THE CONJUNCTION FILLET. SURGERY WAS EXTENDED GREATER THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 915806 | ROUND CALCAR PUNCH MEDIUM | HIP INSTRUMENT | HWP | MICROPORT ORTHOPEDICS INC. | 20070053 | CN101458 | M684200700531 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |