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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US 9.5X60 POLYAXIAL SCREW THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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STRYKER SPINE-US 9.5X60 POLYAXIAL SCREW THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 482619560
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/04/2020
Event Type  Injury  
Event Description

It was reported that during revision surgery to correct the fixation, a xia serrato screw at s2 had fractured post-operatively. The fractured piece was removed but the screw shaft remains inside the patient. Fusion had not been achieved.

 
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Brand Name9.5X60 POLYAXIAL SCREW
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer (Section G)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
-
la chaux-de-fonds 2300
SZ 2300
Manufacturer Contact
rita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key11094942
MDR Text Key224302843
Report Number3005525032-2020-00049
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK170496
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 04/27/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number482619560
Device Catalogue Number482619560
Device LOT NumberB82453
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/22/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/08/2018
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: 12/30/2020 Patient Sequence Number: 1
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