FDA Adverse Event
Injury
Summary report: N
AXIALIF SYSTEM
MDR report key: 1192563
·
Received October 7, 2008
Report
- Report Number
- 3004578806-2008-00023
- Event Type
- Injury
- Date Received
- October 7, 2008
- Date of Event
- September 2, 2008
- Report Date
- September 9, 2008
- Manufacturer
- TRANS1 INC.
- Product Code
- KWP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WEIGHT, AGE AND GENDER ARE NOT KNOWN TO THE MANUFACTURER. THE CODE SELECTED WITH "OTHER" MEANING THAT THE TRAINING, INSPECTION, LOT RECORDS, ETC. WERE EVALUATED. THE CODE OF 326 WAS SELECTED DUE TO DEVIATIONS FROM THE SURGICAL TECHNIQUE BEING EMPLOYED BY THE SURGEON. THE INVESTIGATION REVEALED THE EMPLOYMENT OF A TECHNIQUE VARIATION THAT IS NOT SUPPORTED BY THE SURGICAL TECHNIQUE AS A POSSIBLE CONTRIBUTOR TO THIS INJURY.
Description of Event or Problem · 1
BOWEL INJURY TREATED WITH ANTIBIOTICS AND TEMPORARY DIVERTING COLOSTOMY. PATIENT PRESENTED WITH SYMPTOMS AND WAS READMITTED IN 2008 AFTER ORIGINAL SURGERY ON FIVE DAYS EARLIER. THE INJURY WAS NEAR THE SACRAL PROMONTORY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIALIF SYSTEM | ANTERIOR SPINAL FIXATION | KWP | TRANS1 INC. | 043101007B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |