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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); No Apparent Adverse Event (3189)
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 first of the two screws.
 
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Brand NameXIA DEFORMITY UNIPLANAR SCREW DIAM 5.5 X 40 MM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer (Section G)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR 33610
Manufacturer Contact
rita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key11721013
MDR Text Key247252120
Report Number0009617544-2021-00066
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07613327001037
UDI-Public07613327001037
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
K142381
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/12/2021
1 Device was Involved in the Event
0 Patients were 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
Device Model Number48233540
Device Catalogue Number48233540
Device Lot Number197153
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2021
Was Device Evaluated by Manufacturer? Yes
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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