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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE SOLIS CERVICAL CAGE SIZE H 6 MM L 14 MM; INTERVERTEBRAL BODY FUSION DEVICE.
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STRYKER SPINE-FRANCE SOLIS CERVICAL CAGE SIZE H 6 MM L 14 MM; INTERVERTEBRAL BODY FUSION DEVICE. Back to Search Results
Catalog Number 6741406
Device Problems Fracture (1260); Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2016
Event Type  malfunction  
Event Description
It was reported that the doctor was implanting a solis spacer and upon insertion he allegedly tapped the insert with a mallet and reportedly noticed it had split in half vertically.It was allegedly removed and replaced with new one.
 
Manufacturer Narrative
Visual inspection, material analysis, device history review, complaint history review, risk assessment.The customer reported event was confirmed via visual inspection of the returned device.Material analysis was performed on the cage and concluded that the cage fractured while threaded to an inserter due to an applied cantilever force onto the inserter.No material or manufacturing defects were found.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The probable root cause for the cage fracture is user error, specifically excessive impaction force applied to the cage during insertion.
 
Event Description
It was reported that the doctor was implanting a solis spacer and upon insertion he allegedly tapped the insert with a mallet and reportedly noticed it had split in half vertically.It was allegedly removed and replaced with new one.
 
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Brand Name
SOLIS CERVICAL CAGE SIZE H 6 MM L 14 MM
Type of Device
INTERVERTEBRAL BODY FUSION DEVICE.
Manufacturer (Section D)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR  33610
Manufacturer (Section G)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR   33610
Manufacturer Contact
rakshya bista
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key6169695
MDR Text Key62674341
Report Number0009617544-2016-00490
Device Sequence Number1
Product Code MAX
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number6741406
Device Lot Number166974
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/07/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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