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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CURVE VARIABLE INSERTER; ZYSTON ARC INTERBODY SPACER

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ZIMMER BIOMET SPINE INC. CURVE VARIABLE INSERTER; ZYSTON ARC INTERBODY SPACER Back to Search Results
Catalog Number 14-533021
Device Problem Material Disintegration (1177)
Patient Problem Device Embedded In Tissue or Plaque (3165)
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 number 3012447612-2018-00199.The subject inserter and shaft were used in three procedures within the same hospital with the same outcome prior to manufacturer notification.The inserter is the subject of reports 3012447612-2018-00152, and 3012447612-2018-00200.The shaft is the subject of reports 3012447612-2018-00153, 3012447612-2018-00199, and 3012447612-2018-00201.
 
Event Description
It was reported that it appeared that metal debris was generated as the surgeon was using a mallet to impact the inserter sleeve and shaft to install an implant into the disc space.The surgeon felt that it is possible that the patient may have retained some of the debris.The sleeve and shaft were used to complete the procedure without additional reported patient impacts.This is report one of two for this event.
 
Manufacturer Narrative
Additional information in lot number.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.
 
Manufacturer Narrative
The returned handle was evaluated.There were no indications of material which had separated from the device.A functional evaluation found that the handle operated as expected and no failures were found.A review of the manufacturing records did not identify any issues which would have contributed to this event.
 
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Brand Name
CURVE VARIABLE INSERTER
Type of Device
ZYSTON ARC INTERBODY SPACER
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
Manufacturer (Section G)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
na
westminster CO 80021
Manufacturer Contact
geoffrey gannon
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key7282380
MDR Text Key100429746
Report Number3012447612-2018-00198
Device Sequence Number1
Product Code MAX
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
PK110650
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 05/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number14-533021
Device Lot Number310651
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/22/2018
Initial Date FDA Received02/20/2018
Supplement Dates Manufacturer Received03/02/2018
05/17/2018
Supplement Dates FDA Received03/26/2018
05/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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