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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE MACC S/S MACC CONNECTOR 29MM; IMPLANT-CONNECTOR
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STRYKER SPINE-FRANCE MACC S/S MACC CONNECTOR 29MM; IMPLANT-CONNECTOR Back to Search Results
Catalog Number 48220329
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/28/2014
Event Type  malfunction  
Event Description
It was reported that the sales rep was alerted of a revision surgery.The patient had rods broken in two places.The cross connector failed on removal, two broken screws mid pedicle and with two xia screw heads that have popped off.
 
Event Description
It was reported that the sales rep was alerted of a revision surgery.The patient had rods broken in two places.The cross connector failed on removal, two broken screws mid pedicle and with two xia screw heads that have popped off.
 
Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: the customer reported event of a macc s/s macc connector main body fracture post-op was confirmed via a visual inspection.The appearance of beach marks on the fracture surface is consistent with fatigue fracture.Correspondence with the sales rep confirms that multiple levels had not fused, meaning that the devices at those levels would be tasked with bearing the weight of the spine without added support.Furthermore, it was confirmed that the device was implanted on (b)(6) 2011, which means that the device was implanted for over 3 years, which supports the conclusion that the fracture was likely caused by fatigue of the material.Conclusion: the most likely cause of the breakage is the extended implantation leading to the eventual fatigue of the devices.Non-union of the vertebrae likely contributed to the event as this would have resulted in excess load to the construct.
 
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Brand Name
MACC S/S MACC CONNECTOR 29MM
Type of Device
IMPLANT-CONNECTOR
Manufacturer (Section D)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 3361 0
FR  33610
Manufacturer (Section G)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 3361 0
FR   33610
Manufacturer Contact
daniel roberts
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key4121162
MDR Text Key4942726
Report Number0009617544-2014-00412
Device Sequence Number1
Product Code KWP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060361
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 08/29/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number48220329
Device Lot Number080141
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/05/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received08/29/2014
Was Device Evaluated by Manufacturer? No
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 Age67 YR
Patient Weight73
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