FDA Adverse Event
Summary report: N
*
MDR report key: 3067610
·
Received April 17, 2013
Report
- Report Number
- 3067610
- Date Received
- April 17, 2013
- Date of Event
- March 7, 2013
- Report Date
- April 17, 2013
- Manufacturer
- BOSS INSTRUMENTS, LTD.
- Product Code
- HAE
- Report Source
- User Facility report
- Reporter Location
- MA, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
PHYSICIAN WAS OPERATING ON PATIENT'S NECK WITH A #3 KERRISON, WHEN THE SMALL SCREW FROM THE KERRISON WAS NOTICED TO BE MISSING BY THE PHYSICIAN. A POST-PROCEDURE X-RAY OF ANTERIOR NECK WAS DONE, SCREW NOT FOUND IN X-RAY PER NEGATIVE REPORT. INSTRUMENT WAS REMOVED FROM FIELD AND GIVEN TO MATERIALS COORDINATOR. SCREW WAS THEN FOUND ON STERILE FIELD AND REMOVED FROM AREA. NO HARM TO PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?C6-7 ANTERIOR CERVICAL DISCECTOMY, DECOMPRESSION OF SPINAL CORD FOLLOWED BY ALLOGRAFT FUSION FOLLOWED BY C6-7 ANTERIOR CERVICAL PLATING USING MEDTRONIC VENTURE PLATE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 165651 | * | RONGEUR, MANUAL | HAE | BOSS INSTRUMENTS, LTD. | 70-0332 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |