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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 50 MM PEDICLE SCREW SPINAL SYSTEM

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STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 50 MM PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 482317550
Device Problems Difficult to Insert (1316); Material Deformation (2976); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/26/2017
Event Type  malfunction  
Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment. Results: no relevant manufacturing issues were identified as all units met stryker specifications. The screw threading deformation was confirmed via visual inspection. Conclusion: the root cause is misalignment/ cross threading of the blocker during insertion causing deformation of the threads.
 
Event Description
It was reported that when the surgeon was placing a blocker into the tulip head of the screw, the surgeon said it would not insert correctly due to what was thought to be a result of splayed threading on the tulip head.
 
Event Description
It was reported that when the surgeon was placing a blocker into the tulip head of the screw, the surgeon said it would not insert correctly due to what was thought to be a result of splayed threading on the tulip head.
 
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Brand NameXIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 50 MM
Type of DevicePEDICLE SCREW SPINAL SYSTEM
Manufacturer (Section D)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
-
la chaux-de-fonds 2300
CH 2300
Manufacturer (Section G)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
-
la chaux-de-fonds 2300
CH 2300
Manufacturer Contact
christa marrow
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key6582826
MDR Text Key168719183
Report Number0009617544-2017-00211
Device Sequence Number1
Product Code NKB
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
Type of Report Initial,Followup
Report Date 08/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number482317550
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/08/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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