FDA Adverse Event
Injury
Summary report: N
PROX REAMING GUIDE DIA 12 MM
MDR report key: 7523876
·
Received May 17, 2018
Report
- Report Number
- 1818910-2018-59898
- Event Type
- Injury
- Date Received
- May 17, 2018
- Date of Event
- April 20, 2018
- Report Date
- April 20, 2018
- Manufacturer
- DEPUY FRANCE SAS - 3003895575
- Product Code
- LXH
- UDI-DI
- 10603295116165
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem · 1
IT WAS REPORTED THAT PROX REAMING GUIDE 2307-74-012 STUCK IN HUMERUS. HOLDER 2307-74-001 WOULD NOT REMOVE GUIDE. DOCTOR DID A OSTEOTOME WHICH ALLOWED GUIDE TO BE REMOVED. AFTER OSTEOTOME, HOLDER WAS REATTACHED TO GUIDE FOR REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 365780 | PROX REAMING GUIDE DIA 12 MM | EXTREMITY INSTRUMENTS : PIN GUIDES | LXH | DEPUY FRANCE SAS - 3003895575 | 10603295116165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |