• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 4.5 X 30 PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER SPINE-US XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 4.5 X 30 PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS Back to Search Results
Catalog Number 48144530
Device Problems Screw (568); Mechanical Problem (1384); Mechanical Jam (2983)
Patient Problems Neurological Deficit/Dysfunction (1982); Injury (2348)
Event Date 07/12/2018
Event Type  Injury  
Manufacturer Narrative

Device was not returned to manufacturer.

 
Event Description

It was reported that the surgeon was removing screws and the patient lost motor and ssep monitoring. A screw appeared to be cold welded with the tulip stuck to the screw shank in an angled position. The surgeon was able to remove the tulip and screw from the patient. The case has been aborted. Upon follow up, it was reported that the patient had a neurological deficit on one leg post operatively.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameXIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 4.5 X 30
Type of DevicePEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
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
marta koutsogiannis
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key7754513
MDR Text Key116206554
Report Number0009617544-2018-00188
Device Sequence Number1
Product Code OSH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue Number48144530
Device LOT NumberUNKNOWN
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 Received10/31/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-