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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CURVE VARIABLE INSERTER SHAFT; ZYSTON ARC INTERBODY SPACER
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ZIMMER BIOMET SPINE INC. CURVE VARIABLE INSERTER SHAFT; ZYSTON ARC INTERBODY SPACER Back to Search Results
Catalog Number 14-533041
Device Problem Fracture (1260)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/16/2020
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.
 
Event Description
It was reported that the tip of the zyston curve inserter's draw rod broke off inside a cage during surgery at the time of the final impaction.The cage with the tip was left implanted in the patient and bone was packed behind it.There were no immediate patient impacts reported.
 
Manufacturer Narrative
The complaint is confirmed for one returned inserter shaft for the failure of tip fractured and remains inside the body.Visual inspection revealed the threaded tip has fractured off the inserter shaft.Medical records were not provided for review.Potential cause: the cause of the damage cannot be determined at this time since there is no information available regarding how the inserter was being used or handled at the time of the damage.Dhr review and related actions: per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use: this device is used for treatment.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
It was reported that the tip of the zyston curve inserter's draw rod broke off inside a cage during surgery at the time of the final impaction.The cage with the tip was left implanted in the patient and bone was packed behind it.There were no immediate patient impacts reported.
 
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Brand Name
CURVE VARIABLE INSERTER SHAFT
Type of Device
ZYSTON ARC INTERBODY SPACER
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key10848551
MDR Text Key216831004
Report Number3012447612-2020-00627
Device Sequence Number1
Product Code MAX
UDI-Device Identifier00888480470182
UDI-Public(01)00888480470182(10)PT15D
Combination Product (y/n)N
PMA/PMN Number
K110650
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 02/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number14-533041
Device Lot NumberPT15D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2020
Was the Report Sent to FDA? No
Date Manufacturer Received02/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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