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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA TITANIUM 4.5 POLYAXIAL CROSS CONNECTOR 30-36 MM; PEDICLE SCREW SPINAL SYSTEM.
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STRYKER SPINE-FRANCE XIA TITANIUM 4.5 POLYAXIAL CROSS CONNECTOR 30-36 MM; PEDICLE SCREW SPINAL SYSTEM. Back to Search Results
Catalog Number 48133230
Device Problems Material Deformation (2976); Material Integrity Problem (2978); Physical Property Issue (3008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/13/2017
Event Type  malfunction  
Event Description
It was reported that "when trying to move the crosslink after placing it on the construct, it appears that either the hexdriver stripped or the locking screw stripped out.As a result, we had to remove the rod and manually slide the connector off the rod.Upon grabbing a replacement connector, it was found that the new connectors locking screw was cracked.The surgeons believe that may have been an issue with the first connector.".
 
Manufacturer Narrative
Catalog# 48133230, lot# 105691.Visual inspection; device history review; complaint history review; risk assessment.Device was returned in 2 pieces as the center nut was completely untightened and both screws were deformed.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The plausible root cause of the event is determined to be use error- use of excessive force for final tightening leading to set screw fracture.
 
Event Description
It was reported that "when trying to move the crosslink after placing it on the construct, it appears that either the hexdriver stripped or the locking screw stripped out.As a result, we had to remove the rod and manually slide the connector off the rod.Upon grabbing a replacement connector, it was found that the new connectors locking screw was cracked.The surgeons believe that may have been an issue with the first connector.".
 
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Brand Name
XIA TITANIUM 4.5 POLYAXIAL CROSS CONNECTOR 30-36 MM
Type of Device
PEDICLE SCREW SPINAL SYSTEM.
Manufacturer (Section D)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas NJ 33610
FR  33610
Manufacturer (Section G)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR   33610
Manufacturer Contact
christa marrow
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key6477519
MDR Text Key72587531
Report Number0009617544-2017-00135
Device Sequence Number1
Product Code MNH
Combination Product (y/n)N
Reporter Country CodeUS
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 07/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number48133230
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/19/2010
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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