MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2015-12-01 for UNK ? SPINAL IMPLANT manufactured by Depuy Synthes Spine.
[32398110]
This complaint was generated from literature review conducted in post market surveillance (pms) for health authority reporting purposes. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the pms identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Sample not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[32398111]
Post market surveillance: segmental anterior cervical corpectomy and fusion with preservation of middle vertebrae in the surgical management of 4-level cervical spondylotic myelopathy. European spine journal, 23(7), 1472-1479. Li, z. , guo, z. , hou, s. , zhao, y. , zhong, h. , yu, s. , & hou, t. (2014). N=1: epidural hematoma, n=1 c5 palsy, n=1 axial neck pain, n=2: subsidence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2015-11014 |
| MDR Report Key | 5257674 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2015-12-01 |
| Date of Report | 2015-11-05 |
| Date Mfgr Received | 2015-11-05 |
| Date Added to Maude | 2015-12-01 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL JACENE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5089776485 |
| Manufacturer G1 | DEPUY SYNTHES SPINE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK ? SPINAL IMPLANT |
| Generic Name | UNK ? SPINAL IMPLANT |
| Product Code | JDN |
| Date Received | 2015-12-01 |
| Catalog Number | UNK ? SPINAL IMPLANT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES SPINE |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-01 |