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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ARDIS PEEK IMPLANT 09X09X30; ARDIS INTERBODY SYSTEM
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ZIMMER BIOMET SPINE INC. ARDIS PEEK IMPLANT 09X09X30; ARDIS INTERBODY SYSTEM Back to Search Results
Catalog Number 3201-090930
Device Problem Crack (1135)
Patient Problem No Code Available (3191)
Event Date 06/07/2018
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 a spacer cracked at the insertion threads while being malleted into the disc space during surgery.There was a delay longer than 30 minutes associated with the removal and replacement of the spacer.There were no reported impacts associated with the delay.
 
Manufacturer Narrative
Additional information: (ethnicity).The returned spacer was evaluated.The proximal end of the spacer around the threads has fractured, likely caused by off-axis impaction forces applied to the device during installation.A review of the manufacturing records did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain sufficient instructions regarding device installation.
 
Event Description
It was reported that a spacer cracked at the insertion threads while being malleted into the disc space during surgery.There was a delay longer than 30 minutes associated with the removal and replacement of the spacer.There were no reported impacts associated with the delay.
 
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Brand Name
ARDIS PEEK IMPLANT 09X09X30
Type of Device
ARDIS INTERBODY SYSTEM
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
ashley mcpherson
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key7749135
MDR Text Key116034931
Report Number3012447612-2018-00554
Device Sequence Number1
Product Code MAX
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
PK133184
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
Report Date 11/20/2018
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 Expiration Date09/30/2019
Device Catalogue Number3201-090930
Device Lot Number2432401
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/08/2018
Initial Date FDA Received08/03/2018
Supplement Dates Manufacturer Received11/16/2018
Supplement Dates FDA Received11/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age68 YR
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