CD HORIZON SPINAL SYSTEM
Report
- Report Number
- 1030489-2017-00239
- Event Type
- Injury
- Date Received
- February 3, 2017
- Report Date
- January 9, 2017
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- KWP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PATIENT
Narratives
MULTIPLE DEVICES WERE INVOLVED IN THE EVENT. ALTHOUGH IT IS UNKNOWN WHICH OF THE DEVICES LEAD TO THE EVENT, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES. FOLLOWING DEVICES WERE INVOLVED: PART# 510K# UPN# (B)(4), K042025, (B)(4), K042025 (B)(4). 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.
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT ON (B)(6) 2009 PATIENT UNDERWENT THE FOLLOWING PROCEDURES: TRANSVERSE LUMBAR INTERBODY ARTHRODESIS L4-L5, L5-S1. PEEK INTERBODY CAGE ARTHRODESIS. SUPPLEMENTAL BMP AUTOGRAFT ARTHRODESIS L4-L5, L5-SL. PEDICLE SCREW INSTRUMENTATION L4 TO S1. PREOPERATIVE, POSTOPERATIVE DIAGNOSIS: STATUS POST PREVIOUS LUMBAR DISCECTOMY AT L4-L5, L5-S1. RECURRENT RIGHT L4-L5 DISC. RECURRENT LOW BACK PAIN. INTRACTABLE RIGHT LOWER EXTREMITY PAIN. DISCOGENIC LOW BACK PAIN. FAILURE OF CONSERVATIVE THERAPY. PER OP-NOTES: ¿AFTER DECORTICATING THE ENDPLATES AND TAKING DOWN THE ENDPLATE WE PROCEEDED TO FASHION AN 8MM X 22MM, WE WERE UNABLE TO GET IT COMPLETELY ACROSS. WE TRIED OUR BEST, BUT WE HAD GOOD POSITIONING OF THE GRAFT ITSELF. THE PEEK GRAFT WAS AGAIN SUPPLEMENTED WITH BMP AS WELL AS AUTOGRAFT.¿ ON (B)(6) 2011 PATIENT UNDERWENT CT POST TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-5, L5-S1. FINDINGS: MARKED ECTOPIC BONE GROWTH AND MINIMAL OSTEOLYSIS OR SUBSIDENCE. ON (B)(6) 2010 PATIENT UNDERWENT THE FOLLOWING PROCEDURES: T10-T11 LAMINOTOMY. IMPLANTATION OF SPECIFIED PADDLE LEAD ELECTRODE AND RIGHT ILIAC CREST GENERATOR IMPLANT. INTRAOPERATIVE INTERROGATION OF THE DEVICE. INTRAOPERATIVE FLUOROSCOPY. PREOPERATIVE, POSTOPERATIVE DIAGNOSIS: FAILED BACK SYNDROME, STATUS POST LAMINECTOMY AND FUSION OF L4-5. INTRACTABLE RIGHT LOWER EXTREMITY PAIN, STATUS POST TRIAL OF DORSAL COLUMN STIMULATOR. ON (B)(6) 2012 PATIENT UNDERWENT THE FOLLOWING PROCEDURES: REMOVAL OF RIGHT - SIDED L4 TO S1 SEGMENTAL HARDWARE , EXPLORATION AN FUSION L4-L5 , L5-S1, INSTRUMENTATION OF BILATERAL L4, L5 AND S1; RIG HT-SIDED TRANSPEDICULAR DECOMPRESSION AND COMPLETE FACELECTOMY L5-S1 , RIGHT SIDED TRANSPEDICULAR DECOMPRESSION WITH COMPLETE FACETECTOMY L5 ¿ S1 , L4- S1 POSTEROLATERAL FUSION AND ILIAC BONE MARROW ASPIRATE. AS PER OP-NOTES: ¿AFTER EXPOSURE OF THE HARDWARE, THERE WAS A SHEET OF BONE LOCATED ON TOP OF THE SCREWS AT L4, L5 AND S1. THIS IS LIKELY THE BMP THAT WAS PLACED OVER THE HARDWARE. THIS HAD FORMED A SOLID SHEET OF BONE, BUT WAS NOT INCORPORATED INTO THE VERTEBRAL BODIES OR TRANSVERSE PROCESSES OR LAMINA OR FACET JOINTS OF THE L4, L5 AND S1. THIS BONE WAS THEN REMOVED AND HARVESTED FOR LATER USE. THE INSTRUMENTATION WAS THEN REMOVED BY REMOVING THE SET SCREWS WITH 3 SCREWS AND THEN THE RODS. AFTER THE RODS WERE REMOVED, A SPREADER WAS PLACED BETWEEN THE L4-L5 PEDICLE SCREWS AND THERE WAS OBVIOUS MOTION AT THE L4-L5 JOINT, SAME THING WAS PERFORMED AT L5-S1 WITH AGAIN NO SOLID FUSION IDENTIFIED. THE SCREWS WERE THEN REMOVED AND THE L4 AND S1 SCREWS WERE QUITE LOOSE. THEN EXPOSURE OF THE TRANSVERSE PROCESSES AND FACET JOINTS ON THE RIGHT SIDE WAS COMPLETED AFTER THE HARDWARE WAS REMOVED.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 84018 | CD HORIZON SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MEDTRONIC SOFAMOR DANEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |