FDA Adverse Event
Injury
Summary report: N
DEX II BE 5X18 SC T5 2/0 DT
MDR report key: 800059
·
Received December 29, 2006
Report
- Report Number
- 9681850-2006-00010
- Event Type
- Injury
- Date Received
- December 29, 2006
- Date of Event
- August 11, 2006
- Report Date
- August 15, 2006
- Manufacturer
- GOSPORT - USS
- Product Code
- GAN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DURING A ROUTINE REVIEW OF OUR COMPLAINTS THIS FTR WAS RE-EVALUATED. BECAUSE THE INFO IN THE EVENT DESCRIPTION IS INSUFFICIENT TO SUPPORT A CONCLUSION THAT AN ADVERSE EVENT DID NOT OCCUR, THE COMPLAINT WILL BE REPORTED TO THE FDA AS AN ADVERSE EVENT.
Description of Event or Problem · 1
REPORTEDLY, DURING A NEURO-NECK PROCEDURE, A NEEDLE TIP BROKE OFF. AN X-RAY WAS TAKEN AND THEY FOUND THE TIP OF THE NEEDLE THAT BROKE OFF. THE REST OF THE NEEDLE WAS NOT FOUND. THE PT WAS CLOSED WITHOUT FURTHER COMPLICATION. NO ADD'L INFO WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEX II BE 5X18 SC T5 2/0 DT | ABSORBABLE SYNTHETIC SUTURE | GAN | GOSPORT - USS | * | E6D0828C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |