VERTE-STACK SPINAL SYSTEM
Report
- Report Number
- 1030489-2012-01722
- Event Type
- Injury
- Date Received
- September 27, 2012
- Report Date
- August 29, 2012
- Manufacturer
- MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
- Product Code
- MQP
- PMA / PMN Number
- K041556
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- ATTORNEY
Narratives
THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINED. HOWEVER, THE SUSPECT DEVICES IN USE ARE PART # 2961422, LOT # H08E4072 AND PART # 2961222, LOT # H08E4064. EXPIRATION DATE FOR LOT H08E4072 IS 05/14/2013; EXPIRATION DATE FOR LOT H08E4064 IS 05/28/2013. (B)(4). MANUFACTURE DATE FOR LOT H08E4072 IS 05/29/2008; MANUFACTURE DATE FOR LOT H08E4064 IS 01/16/2008. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.
ADDITIONAL INFORMATION.
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L4-S1 SPONDYLOSIS AND INSTABILITY. THE PATIENT UNDERWENT AN L4-S1 FUSION PROCEDURE USING RHBMP-2/ACS, PEEK INTERBODY SPACERS, AND PEEK POSTERIOR ROD AND SCREW INSTRUMENTATION. TWO INTRAMUSCULAR PAIN PUMPS WERE ALSO PLACED. NO COMPLICATIONS WERE NOTED. AT 140 DAYS POST-OP, THE PATIENT PRESENTED WITH RECURRENT LEG PAIN, AND RECURRENT L4 THROUGH S1 INSTABILITY WITH CAGE MIGRATION OF THE DEVICE PLACED AT L5-S1. THE PATIENT UNDERWENT A REVISION LUMBAR FUSION PROCEDURE USING RHBMP-2/ACS, RESORBABLE CERAMIC GRANULES, PEEK INTERBODY SPACERS, AND POSTERIOR ROD/SCREW INSTRUMENTATION. A LARGER INTERBODY CAGE WAS INSERTED AT L5-S1. NO COMPLICATIONS WERE NOTED.
AT 1360 DAYS POST-OP, THE PATIENT PRESENTED FOR AN OFFICE VISIT. THE PATIENT COMPLAINED OF NOT HAVING SIGNIFICANT IMPROVEMENT DESPITE M ULTIPLE DIFFERENT TREATMENT MODALITIES. THE PATIENT COMPLAINED OF HAVING DEVELOPED WEAKNESS THROUGHOUT HER LEFT LOWER EXTREMITY AND THAT HER LEFT LOWER EXTREMITY AND LEFT LEG GIVES OUT ON HER AND IS NOT STABLE TO WALK ON. THIS EXTENDS TO CRAMPING WITHIN HER CALF MUSCLES.
IT WAS REPORTED THAT ON: (B)(6) 2008, THE PATIENT PRESENTED WITH PREOP DIAGNOSIS OF L4-S1 SPONDYLOSIS AND INSTABILITY AND UNDERWENT L3-S1 LAMINECTOMY AND L4-5 AND L5-1 BILATERAL OSTEOTOMY AND DISCECTOMY WITH INTERBODY FUSION WITH PEEK CAGES WITH AUTO AND ALLOGRAFT BONE AND BMP AS WELL AS L4-S1 BILATERAL OSTEOTOMY AND DISCECTOMY WITH INTERBODY FUSIONS WITH TISSUE, BMP AS WELL AS L4-S1 PEDICLE SCREW FUSION WITH AUTO AND ALLOGRAFT BONE AND BMP WITH INTRAOPERATIVE MICROSCOPY, INTRAOPERATIVE FLUOROSCOPY, IMPLANTATION OF TWO INTRAMUSCULAR PAIN PUMPS THROUGH 2 SEPARATE STAB INCISIONS. PER OP NOTES, "... THE L4 THROUGH S1 SPINOUS PROCESS LAMINAE AND FACETS WERE REMOVED . THE CAGE FILLED WITH AUTO AND ALLOGRAFT BONE AS WELL AS BMP WAS INSERTED INTO EACH OF THE TWO INTERSPACES AND FIT SNUGLY IN PLACE. THE 6.5 MM TITANIUM PEDICLE SCREWS FROM THE MULTIAXIAL SET WERE THEN INSERTED IN L4 THROUGH S1 BILATERALLY UNDER FLUOROSCOPIC GUIDANCE. ALL 6 SCREWS HAD SOLID FUSION WITH BONE. THESE SCREWS WERE TESTED WITH NIM SYSTEM . THE SCREWS WERE CONNECTED TO RODS AND TIGHTENED APPROPRIATELY SO AS TO RESTORE NORMAL SPINE ALIGNMENT. THE PEEK RODS WERE USED. THE TRANSVERSE PROCESSES OF L4 THROUGH S1 BILATERALLY WERE DECORTICATED AND THE BONE REMOVED FROM DECOMPRESSION WAS MORCELIZED AND PLACED INTO THE LATERAL GUTTERS ALONG WITH OSTEOFIL ALLOGRAFT BONE AS WELL AS BMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERTE-STACK SPINAL SYSTEM | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE | MQP | MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |