MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,07 report with the FDA on 2015-05-22 for CHISEL, SURGICAL INSTRUMENT manufactured by Synthes Usa.
[19091818]
This report is being filed after the subsequent review of the following journal article: shim, c. S. , et al. (2007). Posterior avulsion fracture at adjacent vertebral body during cervical disc replacement with prodisc-c. South korea. J spinal disord tech 20:468-472. The study objective was to report posterior avulsion fractures at the adjacent vertebral bodies that occurred during cervical arthroplasty with prodisc-c, which was thought to be related to design of the prosthesis and lack of the prudence in surgical technique. This is a case report of a patient who underwent a total disc replacement (tdr) at c6-c7 with prodisc-c. During the procedure, there was no event noted during the keel cutting chiseling, but approaching the conclusion of chiseling with the box cutting chisel, and following further mallet impaction to advance the chisel slightly deeper, a sudden, copious bleeding occurred and dark-colored blood gushed out from the disc space flowing over the operating field. The instruments were hurriedly removed and the disc space was packed with thrombin-soaked gelfoam pledgets to control the bleeding. After control of the bleeding, the microscope was reapplied to find the source of the bleeding. It was found that posterior central parts of the caudal c6 and cranial c7 vertebral bodies were fractured and avulsed bony fragments were displaced posteriorly compressing the posterior longitudinal ligament and the thecal sac. The displaced bony fragments were removed meticulously taking great care not to damage the spinal cord. Once the fractured posterior parts of the c6 and c7 vertebral bodies had been removed, it was observed that the paths for the keel made at the vertebral endplates were not damaged and insertion of the disc prosthesis seemed possible. Therefore, the prodisc-c disc prosthesis was inserted as planned. The rest of the procedure was completed without incident. Fortunately, the patient awoke without a neurologic deficit and recovered from the surgery uneventfully. Postoperative ct scan showed posterior portions of the c6 and c7 vertebral bodies removed and the disc prosthesis in place. In lateral dynamic views of plain x-rays taken at 3-month follow-up, the prosthesis was in good position without any evidence of migration. The patient showed improvement of motor weakness and was without numbness or pain. This is report 1 of 1 for (b)(4). This report is for an unknown box cutting chisel, unknown part # / lot #.
Patient Sequence No: 1, Text Type: D, B5
[19183931]
Device was used for treatment, not diagnosis. Shim, c. S. , et al. (2007). Posterior avulsion fracture at adjacent vertebral body during cervical disc replacement with prodisc-c. South korea. J spinal disord tech 20:468-472. This report is for an unknown box cutting chisel, unknown part # / lot #. Device is an instrument and is not implanted/explanted. (b)(6). (b)(4). Copious bleeding and avulsed bony fragments compressing the posterior longitudinal ligament and the thecal sac. The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2015-14044 |
| MDR Report Key | 4790223 |
| Report Source | 03,07 |
| Date Received | 2015-05-22 |
| Date of Report | 2015-05-04 |
| Date Mfgr Received | 2015-05-04 |
| Date Added to Maude | 2015-05-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CHISEL, SURGICAL INSTRUMENT |
| Product Code | EML |
| Date Received | 2015-05-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-05-22 |