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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US AVS TL SPACER 9 X 25 X 4 DEG; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
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STRYKER SPINE-US AVS TL SPACER 9 X 25 X 4 DEG; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR Back to Search Results
Catalog Number 48375094
Device Problems Break (1069); Fracture (1260)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 11/07/2018
Event Type  malfunction  
Event Description
The cage broke during surgery, broken fragments were retrieved.Replacement cage was used to complete the surgery.10 minute surgical delay was reported.No adverse consequences to the patient has been reported.
 
Event Description
The cage broke during surgery, broken fragments were retrieved.Replacement cage was used to complete the surgery.10 minute surgical delay was reported.No adverse consequences to the patient has been reported.
 
Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment.Result: the reported event was confirmed via visual inspection of returned product.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.It was also reported that the cage was impacted with straight impactor via high amount of force.Conclusion: the root cause of the reported event was determined to be user error- too much impaction force.
 
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Brand Name
AVS TL SPACER 9 X 25 X 4 DEG
Type of Device
INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key8125579
MDR Text Key129302415
Report Number0009617544-2018-00288
Device Sequence Number1
Product Code OVD
UDI-Device Identifier07613153046646
UDI-Public07613153046646
Combination Product (y/n)N
PMA/PMN Number
K143163
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 03/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number48375094
Device Lot Number84576
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2018
Date Manufacturer Received02/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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