FDA Adverse Event
Malfunction
Summary report: N
ACUFIX/THINLINE
MDR report key: 761536
·
Received November 11, 2005
Report
- Report Number
- 1649384-2005-00063
- Event Type
- Malfunction
- Date Received
- November 11, 2005
- Date of Event
- May 16, 2004
- Report Date
- November 10, 2005
- Manufacturer
- ABBOTT SPINE
- Product Code
- KWQ
- Removal / Correction Number
- 1649384-11/1/05-002-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL CATALOG NUMBERS: 402-40113 X2; 403-2036.
Description of Event or Problem · 1
IT WAS REPORTED THAT IT WAS NOTED ON A FOLLOW UP APPOINTMENT THAT THE SCREWS AND SWIVELS HAD PULLED THROUGH THE PLATE. THERE ARE NO PLANS FOR REVISION SURGERY AT THIS TIME. THE INITIAL REPORTED MDR THAT WAS REFERENCED AS 1649384-2005-00011 WAS A COMBINED REPORT OF THREE SEPARAE EVENTS FROM 5/5/2004 (1649384-2005-00011) AND 5/6/2004 (1649384-2005-00064) AND 5/16/2004 (1649384-2005-00063). THE INFORMATION HAS BEEN REVIEWED AND SEPARATE MEDICAL DEVICE REPORTS ARE BEING FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUFIX/THINLINE | CERVICAL PLATE AND SCREWS | KWQ | ABBOTT SPINE | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |