MAUDE Adverse Event Report: DEPUY SYNTHES SPINE HEX END ROD, 300MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 179762300

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

Patient Problem Sudden Cardiac Death (2510)

Event Date 12/30/2016

Event Type  Death  

Manufacturer Narrative

Complaint will be reported as adverse event.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.All patient deaths reported to depuy spine in which depuy spine device(s) have been or were being implanted will be reported as mdr events regardless of causality.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Dr.B)(6) was on spine trauma call at b)(6).The patient presented at the emergency room approximately b)(6) 2016 with a t12-l1 extension distraction fracture (has ankylosing spondylitis).Dr.B)(6) attempted surgery on the patient on b)(6) 2016 to treat the unstable fracture.The patient had cardiac issues and the surgery was never started.On b)(6) 2016 the patient began losing neurological function.Dr.B)(6) attempted the surgery again on b)(6) 2016 after the patient began losing neurological function.Dr.B)(6) placed confidence cement in t10-l3 along with expedium screws at all levels except for l1 (fracture level).While beginning to prepare for rod placement the patient became ¿hypotensive¿ and dr.B)(6) placed a temporary rod on the left.The patient then again became ¿hypotensive¿ while dr.B)(6) was bending the right rod.At this point dr.B)(6) began performing a quick wound closure on the patient.The patients hypotension continued.The anesthesia team performed cpr after wound closure.They could not resuscitate the patient.The patient expired at 22:23 on b)(6) 2016.

• Brand Name: HEX END ROD, 300MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6280590
• MDR Text Key: 65851486
• Report Number: 1526439-2017-10060
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111136
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 179762300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2016
• 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
• Patient Age: 85 YR