FDA Adverse Event
Malfunction
Summary report: N
NUVASIVE HELIX MINI ACP SYSTEM
MDR report key: 2140342
·
Received June 16, 2011
Report
- Report Number
- 2031966-2011-00024
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- April 19, 2011
- Report Date
- June 15, 2011
- Manufacturer
- NUVASIVE, INC.
- Product Code
- KWQ
- PMA / PMN Number
- K073275
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NUVASIVE REFERENCE (B)(4). THE AFFECTED PRODUCT HAS NOT BEEN EXPLANTED AND IS NOT YET AVAILABLE FOR EVAL. NO ROOT CAUSE HAS BEEN ESTABLISHED. THE PT WILL CONTINUE TO BE MONITORED BY THE SURGEON. SHOULD THE PRODUCT BECOME AVAILABLE FOR EVAL AND PERTINENT NEW INFO IS OBTAINED, A F/U REPORT WILL BE FILED.
Description of Event or Problem · 1
A 2-LEVEL ACDF WAS PERFORMED ON A (B)(6) MALE PT ON (B)(6) 2011. F/U RADIOGRAPHS TAKEN ON (B)(6) 2011 NOTED THE CENTER SCREW HAD SEPARATED FROM THE PLATE BUT APPEARED TO BE ANCHORED IN THE VERTEBRAL BODY. NO INJURY OR CLINICAL SEQUELAE WERE REPORTED TO HAVE OCCURRED. THERE HAS BEEN NO REVISION SURGERY PERFORMED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUVASIVE HELIX MINI ACP SYSTEM | SPINAL INT VERT BODY FIXATION ORTHOSIS | KWQ | NUVASIVE, INC. | 7741115 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |