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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CNNLTD 5.5 PLYSCRW 6.5X40; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
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ZIMMER BIOMET SPINE INC. CNNLTD 5.5 PLYSCRW 6.5X40; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 3505-6540
Device Problem Unintended Movement (3026)
Patient Problem Tissue Damage (2104)
Event Date 01/26/2020
Event Type  Injury  
Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.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.Reference report 3012447612-2020-00138.
 
Event Description
It was reported that during a spinal fracture procedure, two screws backed out of the bone as the surgeon was tightening the closure tops over the rod.One of the screws was replaced with a larger diameter screw while the other screw required the surgeon to advance to an adjacent level to complete the case.Additionally, one of the removed screws was reported to have dissembled once removed.This is report two of two for this event.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information in h3 and h4 - method, results, and conclusions visual examination of the returned product identified that the threads are stripped.Visual investigation of tulip aag shows that it is broken; the inner metal ring and screw have disassembled from the tulip.Visual investigation of tulip aal shows no deformities.Functional test of this tulip-screw combination with rod pn: 3510-080 ln: 63dd and locking screw 75jq reveals that the aal screw and tulip are fully functional.The event is confirmed.Review of the device history record identified no deviations or anomalies during manufacturing.Devices are used for treatment.The reported products were reviewed for compatibility with no issues noted.Review of complaint history identified additional similar complaints for the reported items and no additional complaints for the reported part and lot combinations.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.A follow-up report will be submitted if new information is received that changes the information provided in this report.
 
Event Description
It was reported that during a spinal fracture procedure, two screws backed out of the bone as the surgeon was tightening the closure tops over the rod.One of the screws was replaced with a larger diameter screw while the other screw required the surgeon to advance to an adjacent level to complete the case.Additionally, one of the removed screws was reported to have dissembled once removed.This is report two of two for this event.
 
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Brand Name
CNNLTD 5.5 PLYSCRW 6.5X40
Type of Device
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key9753754
MDR Text Key180857096
Report Number3012447612-2020-00139
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K132884
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number3505-6540
Device Lot NumberAAG
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2020
Was the Report Sent to FDA? No
Date Manufacturer Received11/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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