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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF TL 10-16 MM X 11 MM X 34 MM X 0 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE
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STRYKER SPINE-US ACCULIF TL 10-16 MM X 11 MM X 34 MM X 0 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE Back to Search Results
Catalog Number 305010
Device Problems Collapse (1099); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/13/2016
Event Type  malfunction  
Event Description
It was reported that; the implant collapsed once we were final tightened.We had ap and lateral films of the implant expanded intro op.We also have ap and lateral films of the implant collapse once all the screws were all final tightened.We did not replace the cage.
 
Manufacturer Narrative
Device history review, complaint history review, risk assessment.The implant remains implanted and is unavailable for evaluation.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Because the implant was not returned for evaluation the root cause could not be determined conclusively.
 
Event Description
It was reported that; the implant collapsed once we were final tightened.We had ap and lateral films of the implant expanded intro op.We also have ap and lateral films of the implant collapse once all the screws were all final tightened.We did not replace the cage.
 
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Brand Name
ACCULIF TL 10-16 MM X 11 MM X 34 MM X 0 DEG CAGE
Type of Device
INTERVERTEBRAL BODY FUSION DEVICE
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer (Section G)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer Contact
rakshya bista
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key6234129
MDR Text Key64591796
Report Number3004024955-2017-00002
Device Sequence Number1
Product Code MAX
UDI-Device Identifier07613327068061
UDI-Public(01)07613327068061
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143616
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number305010
Device Lot Number09251505
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/13/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/16/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age39 YR
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