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-US XIA DEFORMITY UNIPLANAR SCREW DIAM 5.5 X 40 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-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.
 
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.
 
Manufacturer Narrative
The device has been received and upon receipt d4 (lot #) has been corrected from '190449' to '197153'.
 
Manufacturer Narrative
B.5 has been corrected following new information received and investigation completion.Visual inspection confirmed that tulip did not disengage and that there is no deformation on this product.Report 0009617544-2021-00067 addresses the complaint of the tulip disengagement, as visual inspection confirmed that the tulip did disengage in that record.
 
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 first returned screw which shows no signs of tulip disengagement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11721013
MDR Text Key247252120
Report Number0009617544-2021-00066
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
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
Initial Date Manufacturer Received 03/26/2021
Initial Date FDA Received04/23/2021
Supplement Dates Manufacturer Received05/04/2021
06/29/2021
Supplement Dates FDA Received05/25/2021
07/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-