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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US XIA DEFORMITY UNIPLANAR SCREW DIAM 5.5 X 40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US XIA DEFORMITY UNIPLANAR SCREW DIAM 5.5 X 40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 48233540
Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/26/2021
Event Type  malfunction  
Event Description
It was reported that the tulips of 2 xia uniplanar screws disengaged from their respective screw shafts intra-operatively.Subsequently, there was a 60 minute delay to surgery as the surgeon removed the screws and rods on both sides to redo the construct.The procedure was completed successfully.This report captures the second of the two screws.
 
Event Description
It was reported that the tulips of 2 xia uniplanar screws disengaged from their respective screw shafts intra-operatively.Subsequently, there was a 60 minute delay to surgery as the surgeon removed the screws and rods on both sides to redo the construct.The procedure was completed successfully.This report captures the second of the two screws.
 
Manufacturer Narrative
D4 has been updated following receipt of the device.
 
Manufacturer Narrative
B.5 has been corrected following new information received and investigation completion.Visual: visual inspection confirmed tulip disengagement.Deformation was observed on shank bulb from the rod.This deformation is on the outer edge of shank bulb.The direction of deformation also indicates that the rod axis was not in line with the uniplanar axis of the tulip.Additional deformation is seen on the star patterned driver engagement surface.Deformation is observed on the locking ring of the tulip.Deformation on locking ring is observed in more than one position.Device history records were reviewed for this lot, no relevant manufacturing issues were identified.Complaint history records were reviewed for this lot, similar complaints were identified.Visual inspection shows that multiple maneuvers were performed simultaneously or consecutively that put excess stress on the screw tulip.Evidence of this is shown in the multiple deformations on the tulip locking ring as well as the deformation left on the screw shank bulb, which was out of line with the tulip axis.Likely cause is due to excessive angulation and excessive force applied as seen in the deformation on the screw and tulip locking ring.
 
Event Description
It was initially reported that the tulips of 2 xia uniplanar screws disengaged from their respective screw shafts intra-operatively.However, after additional information received and investigation completion, 8 screw tulips disengaged.Subsequently, there was a 60 minute delay to surgery as the surgeon removed the screws and rods on both sides to redo the construct.The procedure was completed successfully.This report captures the sixth of the eight screws.
 
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Brand Name
XIA DEFORMITY UNIPLANAR SCREW DIAM 5.5 X 40 MM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key11721014
MDR Text Key247251097
Report Number0009617544-2021-00067
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07613327001037
UDI-Public07613327001037
Combination Product (y/n)N
PMA/PMN Number
K142381
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 07/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number48233540
Device Catalogue Number48233540
Device Lot Number197153
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2021
Date Manufacturer Received06/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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