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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE RADIUS CROSS CONNECTOR 20MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS
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STRYKER SPINE-FRANCE RADIUS CROSS CONNECTOR 20MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS Back to Search Results
Catalog Number 486614220
Device Problems Disconnection (1171); Material Deformation (2976); Naturally Worn (2988)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/20/2015
Event Type  malfunction  
Event Description
It was reported that; during radius surgery, surgeon tried to set the connector to rods and attached it forcibly.Then one of the set screw of the connector became not be fastened.It was worn.The surgeon used other connector and finished the surgery.
 
Manufacturer Narrative
Lot code: 11c702.Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: the radius cross connector 20mm was confirmed to be worn and one screw is not functional upon device inspection.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.Conclusion: based on the reported event details and the observed wear/deformation on the connector's one screw head, the plausible root cause is user related.
 
Event Description
It was reported that; during radius surgery, surgeon tried to set the connector to rods and attached it forcibly.Then one of the set screw of the connector became not be fastened.It was worn.The surgeon used other connector and finished the surgery.
 
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Brand Name
RADIUS CROSS CONNECTOR 20MM
Type of Device
SPINAL INTERLAMINAL FIXATION ORTHOSIS
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
linford leitch
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key4849085
MDR Text Key16862543
Report Number0009617544-2015-00271
Device Sequence Number1
Product Code KWP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K070631
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,health professional
Reporter Occupation Other
Type of Report Initial
Report Date 05/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number486614220
Device Lot Number11C702
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/20/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2011
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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