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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE PATHFINDER NXT (PEDICAL SCREW SYSTEM) EXTENDER SLEEVE REDUCTION LONG

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ZIMMER SPINE PATHFINDER NXT (PEDICAL SCREW SYSTEM) EXTENDER SLEEVE REDUCTION LONG Back to Search Results
Model Number N/A
Device Problem Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/01/2016
Event Type  Injury  
Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event. A follow up report will be sent upon completion of the device evaluation. Report two of two for the same event, reference 0002184052-2016-00239.

 
Event Description

It was reported when the surgeon advanced the closure top for final torque, however final tightening was not allowable because threads on closure top sheared off. It is believed the extension sleeve dissociated from the screw head causing threads to jump, and eventually shear off. The surgeon tried another closure top but had the same results. It was a 2 level construct and closure top threads sheared off during the final torque in the middle level of the contralateral side. The surgeon torqued off the top and bottom of the construct as well as the three screws on the ipselateral side. There were 5 points of fixation, so the surgeon was comfortable leaving the middle screw on the contralateral side open. The surgery was completed, there was a fifteen minute delay and the patient did not retain a foreign body.

 
Manufacturer Narrative

The returned sleeve was evaluated. It was functionally checked with mating components and found to operate as expected; the complaint cannot be confirmed for the sleeve. A review of the manufacturing records did not identify any issues which would have contributed to this event.

 
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Brand NamePATHFINDER NXT (PEDICAL SCREW SYSTEM)
Type of DeviceEXTENDER SLEEVE REDUCTION LONG
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
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key5987067
MDR Text Key55923152
Report Number0002184052-2016-00240
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK132884
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number3557-2300
Device LOT Number84PE
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/12/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/17/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 09/29/2016 Patient Sequence Number: 1
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