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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP POLYAXIAL SCREW 6.5 X 45MM PEDICLE SCREW SPINAL SYSTEM

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STRYKER SPINE-SWITZERLAND XIA LP POLYAXIAL SCREW 6.5 X 45MM PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Model Number 03821645
Device Problems Difficult to Insert (1316); Device Operates Differently Than Expected (2913); Material Deformation (2976)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 04/28/2017
Event Type  Injury  
Event Description

It was reported that; when doctor used the spreader to distract the screws ,he found the reduction polyaxial screws's head fixed and cannot move any more. The doctor according to the fixed screw way using the screw. However, caused great difficulties of installation rod, operation time delay.

 
Manufacturer Narrative

Method: device history review, complaint history review, risk assessment; result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified. The device. Has not been returned as it remains implanted in the patient and is unavailable for inspection conclusion: the plausible root cause of the event cannot be determined as the device remains implanted and is unavilable for inspection.

 
Event Description

It was reported that; when doctor used the spreader to distract the srcews, he found the reduction polyaxial screws's head fixed and cannot move any more. The doctor according to the fixed screw way using the screw. However, caused great difficulties of installation rod, operation time delay.

 
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Brand NameXIA LP POLYAXIAL SCREW 6.5 X 45MM
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
rakshya bista
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key6645135
MDR Text Key77697287
Report Number3005525032-2017-00069
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeCN
PMA/PMN NumberK060361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/19/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/15/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number03821645
Device Catalogue Number03821645
Device LOT NumberB42212
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/28/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/15/2017 Patient Sequence Number: 1
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