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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF PL 8-12MM X 11MM X 27 MM X 8 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE
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STRYKER SPINE-US ACCULIF PL 8-12MM X 11MM X 27 MM X 8 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE Back to Search Results
Catalog Number 400008
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/29/2016
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the surgeon made aware of a collapsed pl cage.Cage was implanted on (b)(6) 2014.
 
Additional Manufacturer Narrative
Device history review, complaint history review, risk assessment.A manufacturing review of the device was performed and indicated no discrepancies or anomalies.The device remains implanted therefore a plausible root cause cannot be identified conclusively.
 
Event or Problem Description
It was reported that the surgeon made aware of a collapsed pl cage.Cage was implanted on (b)(6) 2014.
 
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Brand Name
ACCULIF PL 8-12MM X 11MM X 27 MM X 8 DEG CAGE
Common Device Name
INTERVERTEBRAL BODY FUSION DEVICE
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key6196360
Report Number3004024955-2016-00108
Device Sequence Number16411681
Product Code MAX
UDI-Device Identifier07613327066760
UDI-Public(01)07613327066760
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K143616
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 02/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Catalogue Number400008
Device Lot Number06031401
Was Device Available for Evaluation? No
Type of Report(Section G)FDA Requested
Initial Date Received by Manufacturer 11/29/2016
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date12/21/2016
Supplement Report FDA Received Date02/08/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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