MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXPEDIUM 5.5 TI PRE-LORDOSED ROD, 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 179771045

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

Patient Problem Sudden Cardiac Death (2510)

Event Date 06/10/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Complaint will be reported as adverse event.There is no indication that the depuy spine devices caused or contributed to the event.It was reported patient expired two days post-surgery.Patient underwent a transforaminal posterior lumbar interbody fusion (tplif) from l5-s1 for central stenosis on (b)(6) 2016.Surgery was successfully completed with no complications.Surgeon suspected heart attack however, it is unknown if patient had pre-existing heart issues.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.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Sample not available.

Event Description

Notified by synthes customer quality: it was reported patient expired two days post-surgery.Patient underwent a transforaminal posterior lumbar interbody fusion (tplif) from l5-s1 for central stenosis on (b)(6) 2016.Surgery was successfully completed with no complications.Patient was last checked at night on (b)(6) 2016 and was reported as stable.The nurse revisited the patient in the morning (unknown time) on (b)(6) 2016 and patient was coded.Patient is an organ donor and his heart and tissues were harvested.Autopsy results have not been provided to surgeon at this time.Surgeon suspected heart attack however, it is unknown if patient had pre-existing heart issues.

• Brand Name: EXPEDIUM 5.5 TI PRE-LORDOSED ROD, 45MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 5813539
• MDR Text Key: 50172546
• Report Number: 1526439-2016-10500
• 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: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 179771045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 46 YR