Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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-FRANCE XIA TITANIUM 4.5 POLYAXIAL CROSS CONNECTOR 36-45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
  • 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-FRANCE XIA TITANIUM 4.5 POLYAXIAL CROSS CONNECTOR 36-45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 48133236
Device Problems Difficult to Insert (1316); Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/20/2020
Event Type  malfunction  
Event Description
It was reported that two xia titanium 4.5 polyaxial cross connector securing mechanisms jammed intra-operatively.There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay.This report represents the first of two cross connectors.
 
Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.As the device was not returned, a definite root cause cannot be determined.Possible root causes include connector in the wrong location or off- axis, hex disengagement due to cantilever force, non optimal screw placement, poor rod bending and/or hex screw initially torqued in the wrong direction.
 
Event Description
It was reported that two xia titanium 4.5 polyaxial cross connector securing mechanisms jammed intra-operatively.There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay.This report represents the first of two cross connectors.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
XIA TITANIUM 4.5 POLYAXIAL CROSS CONNECTOR 36-45 MM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR  33610
MDR Report Key10072698
MDR Text Key191829017
Report Number0009617544-2020-00069
Device Sequence Number1
Product Code NKB
UDI-Device Identifier04546540515094
UDI-Public04546540515094
Combination Product (y/n)N
PMA/PMN Number
K121342
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number48133236
Device Catalogue Number48133236
Device Lot Number178940
Was Device Available for Evaluation? No
Date Manufacturer Received08/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-