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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF TL 8-12 MM X 11MM X 34 MM X 0 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE

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STRYKER SPINE-US ACCULIF TL 8-12 MM X 11MM X 34 MM X 0 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE Back to Search Results
Catalog Number 305008
Device Problems Collapse (1099); Mechanical Problem (1384); Migration or Expulsion of Device (1395)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 01/30/2017
Event Type  Injury  
Event Description
It was reported that; implant collapsed and retropulsed.Revision surgery performed 4 weeks after initial.Cage removed and new cage inserted.
 
Manufacturer Narrative
Lot# 09231502; visual inspection; device history review; complaint history review; risk assessment.Manufacturing review of the device was performed and indicated no discrepancies or anomalies.The root cause could not be determined.
 
Event Description
It was reported that; implant collapsed and retropulsed.Revision surgery performed 4 weeks after initial.Cage removed and new cage inserted.
 
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Brand Name
ACCULIF TL 8-12 MM X 11MM 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
christa marrow
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key6358177
MDR Text Key68350996
Report Number3004024955-2017-00013
Device Sequence Number1
Product Code MAX
UDI-Device Identifier07613327068054
UDI-Public(01)07613327068054
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 04/26/2017
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 No Information
Device Catalogue Number305008
Device Lot Number09231502
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/30/2017
Initial Date FDA Received02/24/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/09/2015
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 Outcome(s) Required Intervention;
Patient Age36 YR
Patient Weight118
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