FDA Adverse Event
Injury
Summary report: N
AXIALIF SYSTEM
MDR report key: 689970
·
Received March 17, 2006
Report
- Report Number
- 3004578806-2006-00003
- Event Type
- Injury
- Date Received
- March 17, 2006
- Date of Event
- February 23, 2006
- Report Date
- March 17, 2006
- Manufacturer
- TRANS1 INCORPORATED
- Product Code
- JDN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ABCESS IN PERSACRAL SPACE. DURING SURGERY, PROTECTIVE CHANNEL BECAME DISENGATED FROM SACRUM AND CUTTER WAS UNPROTECTED IN THE PRE-SACRAL SPACE. IT IS MOST PORBABLE THAT THE INFECTION WAS CAUSED BY A LACERATION OF THE BOWEL CAUSED BY THE UNPROTECTED CUTTER. SINCE THE INFECTION HAD BEN UNRESPONSIVE TO PRIOR TREATMENT, THE HOSPITAL'S INFECTION SPECIALIST RECOMMENDED REMOVAL OF THE IMPLANT. THE DISC SPACE AND PRESACRAL TRACT WERE FLUSHED WITH A LARGE VOLUME OF RINGER'S SOLUTION. THE HOSPITAL IS MAKING ADDITIONAL EFFORTS TO RESOLVE THE INFECTION. THE SPECIFICS OF THESE EFFORTS ARE NOT KNOW TO TRANS1.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIALIF SYSTEM | ANTERIOR SPINAL FIXATION IMPLANT | JDN | TRANS1 INCORPORATED | NA | 043113605I |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |