MAUDE Adverse Event Report: DEPUY SYNTHES SPINE UNK SPINAL IMPLANT; UNK ¿ SPINAL IMPLANT

Catalog Number UNK ¿ SPINAL IMPLANT

Device Problem Device Slipped (1584)

Patient Problems Hematoma (1884); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: UNK SPINAL IMPLANT
• Type of Device: UNK ¿ SPINAL IMPLANT
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 5257639
• MDR Text Key: 32412633
• Report Number: 1526439-2015-11015
• Device Sequence Number: 1
• Product Code: JDN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial
• Report Date: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK ¿ SPINAL IMPLANT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2015
• Initial Date FDA Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other