MAUDE Adverse Event Report: DEPUY SYNTHES SPINE NO PRODUCT FAILURE

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

Patient Problem Death (1802)

Event Date 10/15/2014

Event Type  Death  

Event Description

The patient is male and (b)(6), did herniated disk surgery on (b)(6) 2014 with spine products.No abnormal issue occurred during surgery procedure.The patient died in hospital after 2 weeks of post-operation.

Manufacturer Narrative

Complaint is a reportable adverse event.No product failure indicted.The patient died 2 weeks post operatively after surgery to repair a herniated disk.No abnormal issue occurred during surgery procedure.No known co-morbities / concomitant medical conditions which identified the patient at a higher risk for complication or death were reported.The surgeon claims the procedure had been done successfully.No autopsy will be performed.There is no indication that the depuy spine devices caused or contributed to the event.No reported malfunction or failure in the instruments and implants.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Sample not available for investigation.

Manufacturer Narrative

Corrected data: 12-month review of the complaint trend analysis was conducted on the patient harm-spine: adverse event: death rather than the product code as there were no product failure detected with the reported devices.Trending search indicated zero complaints, other than this complaint file, relating to the patient harm (see attached file: (b)(4) month trending-adverse event: death.Pdf).In this complaint file there was a reported harm following the death of the patient 2 weeks postoperatively.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting per work instruction (wi-8887) and worldwide post market surveillance per standard enterprise procedure ((b)(4)).The root cause cannot be determined as there were no issues found with the reported devices.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: NO PRODUCT FAILURE
• Type of Device: UNK
• 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: 4815463
• MDR Text Key: 5925453
• Report Number: 1526439-2015-10518
• 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: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2015

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: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/06/2015
• Initial Date FDA Received: 06/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 58 YR