FDA Adverse Event
Injury
Summary report: N
ISOBAR SPINAL SYSTEM
MDR report key: 770272
·
Received October 13, 2006
Report
- Report Number
- 3003807094-2006-00002
- Event Type
- Injury
- Date Received
- October 13, 2006
- Date of Event
- April 29, 2005
- Report Date
- May 5, 2005
- Manufacturer
- SCIENT'X USA, INC.
- Product Code
- NQP
- PMA / PMN Number
- k990118
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ROD CUT TOO SHORT DURING SURGERY. ADD'L LOT# 988L.
Description of Event or Problem · 1
IN 2005 PREOP DIAGNOSIS SPINAL STENOSIS WITH LUMBAR INTERVETEBRAL DISC DEGENERATION. THREE MONTHS LATER, SURGICAL TREATMENT L2 - SACRUM LAMINECTOMY; PSF WITH BONEGRAFT AND INSTRUMENTATION. DATE UNK - X-RAY SHOWED A DISLODGED ROD AT S1 SCREWS. ELEVEN DAYS LATER - SURGICAL PROCEDURE TO APPROPRIATELY PLACE CONTOURED RODS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISOBAR SPINAL SYSTEM | PEDICLE SCREW SPINAL SYSTEM | NQP | SCIENT'X USA, INC. | * | 546L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other |