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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE ZIMMER PATHFINDER PEDICLE SCREWS

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ZIMMER SPINE ZIMMER PATHFINDER PEDICLE SCREWS Back to Search Results
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.
 
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Brand NameZIMMER PATHFINDER PEDICLE SCREWS
Type of DevicePEDICLE 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 Key5896683
MDR Text Key52771165
Report Number0002184052-2016-00166
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received08/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2016
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 Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 08/23/2016 Patient Sequence Number: 1
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