FDA Adverse Event
Malfunction
Summary report: N
KERRISON DETACH 130DG UP 200MM
MDR report key: 4213912
·
Received October 6, 2014
Report
- Report Number
- 2916714-2014-00780
- Event Type
- Malfunction
- Date Received
- October 6, 2014
- Report Date
- October 6, 2014
- Manufacturer
- AESCULAP AG AND CO. KG
- Product Code
- GXJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MFG SITE EVAL: EVAL ON-GOING.
Description of Event or Problem · 1
DURING CERVICAL SPINE PROCEDURE, THE KERRISON TIP BROKE OFF. SURGICAL DELAY OF 5 MINUTES. PT WAS NOT AFFECTED. NO ADD'L TESTS WERE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 625113 | KERRISON DETACH 130DG UP 200MM | BONE PUNCH | GXJ | AESCULAP AG AND CO. KG | FL961B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |