MAUDE Adverse Event Report: DEPUY SYNTHES SPINE DEPUY SYNTHES SPINE CONNECTOR

Catalog Number UNK ¿ SPINAL IMPLANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation 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.

Event Description

Surgeon presentation reviewed by medical.Pt.Had a very complicated course and underlying disease with poor bone quality (multiple revisions for adjacent kyphosis, screw pull-out), per history provided in slides by surgeon.Pt.Wasn锠instrumented in the c-spine (instrumentation stopped in thoracic), but collapsed at cervical level and had spinal cord injury, death.Professional education confirmed with surgeon that only the connectors were depuy synthes spine.

• Brand Name: DEPUY SYNTHES SPINE CONNECTOR
• Type of Device: DEPUY SYNTHES SPINE CONNECTOR
• 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: 5267332
• MDR Text Key: 32683839
• Report Number: 1526439-2015-11028
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: UNK ¿ SPINAL IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/06/2015
• Initial Date FDA Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 66 YR