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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US XIA DEFORMITY REDUCTION LONG ARM MONOAXIAL SCREW 6.5 X 45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US XIA DEFORMITY REDUCTION LONG ARM MONOAXIAL SCREW 6.5 X 45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 03828645
Device Problem Fracture (1260)
Patient Problem Injury (2348)
Event Date 05/13/2020
Event Type  Injury  
Manufacturer Narrative
Status and location of the device is unknown.
 
Event Description
It was reported that two xia deformity long arm monoaxial screws fractured post-operatively.Radiography showed that the two screws had fractured and that the patient had fused.Revision surgery was performed and the two screws were successfully removed.This report represents the first of the two screws.
 
Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.However, photos were provided showing the screws fractured at the threaded shaft section.Device and complaint history records were reviewed and no relevant manufacturing issues were identified as all units met stryker specifications.From the xia ifu: while the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.However, due to the many biological, mechanical and physicochemical factors which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.These implants are temporary internal fixation devices designed to stabilize the operative site during the normal healing process.After healing occurs, these devices serve no functional purpose and can be removed.Based on the length of implantation and the fact that the patient fused, the most likely root cause is due to fatigue fracture.
 
Event Description
It was reported that two xia deformity long arm monoaxial screws fractured post-operatively.Radiography showed that the two screws had fractured and that the patient had fused.Revision surgery was performed and the two screws were successfully removed.This report represents the first of the two screws.
 
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Brand Name
XIA DEFORMITY REDUCTION LONG ARM MONOAXIAL SCREW 6.5 X 45MM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key10136034
MDR Text Key194624845
Report Number0009617544-2020-00082
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07613154407644
UDI-Public07613154407644
Combination Product (y/n)N
PMA/PMN Number
K061854
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number03828645
Device Catalogue Number03828645
Device Lot Number172741
Was Device Available for Evaluation? No
Date Manufacturer Received07/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age24 YR
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