MAUDE Adverse Event Report: ZIMMER SPINE ZIMMER PATHFINDER PEDICLE SCREWS

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem Sudden Cardiac Death (2510)

Event Date 03/10/2016

Event Type  Death  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The part and lot numbers are unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

Zimmer biomet company representative came across an mdr that references pathfinder screws.(b)(4).Received a complaint for their product that involved pathfinder screws.(b)(4) aware date -(b)(6) 2016.Event description: a male underwent an xlif procedure at l2-l5 with no problems reported.A posterior spinal correction involving a ponte osteotomy was performed at l5-s1.The procedure was 7 hours long as a result of difficulty with screw back out during final tightening with a blood loss total of 2000cc.J&j viper sacral-alariliac screws as well as zimmer pathfinder pedicle screws were used in conjunction with (b)(4) interbody implants.During closure of the surgical wound the patient suffered a cardiac failure and expired.

• Brand Name: ZIMMER PATHFINDER PEDICLE SCREWS
• Type of Device: PEDICLE SCREWS
• Manufacturer (Section D): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer (Section G): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer Contact: michelle cole ; 7375 bush lake road; minneapolis, MN 55439 ; 9528325600
• MDR Report Key: 5896683
• MDR Text Key: 52771165
• Report Number: 0002184052-2016-00166
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2016
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Death