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-SWITZERLAND XIA PRECISION SCREW 7.5 X 55MM; PEDICLE SCREW SPINAL 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-SWITZERLAND XIA PRECISION SCREW 7.5 X 55MM; PEDICLE SCREW SPINAL SYSTEM. Back to Search Results
Model Number 48231755
Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/20/2017
Event Type  malfunction  
Event Description
It was reported that; the rod was cut.While bending the vitallium rod with the french bender the product broke in half on the back table about 2 inches in.During surgery while putting the rod in the screw the head fell off of the screw.The screw was already in the patient.All broken fragments retrieved.
 
Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment; the customer reported event was confirmed via visual inspection.The screw was returned in 2 pieces.The tulip head was disengaged from the main thread body.No relevant manufacturing issues were identified as all units met specifications.The plausible root cause of the event was determined to be excessive insertion force applied during insertion leading to disengagement.
 
Event Description
It was reported that; the rod was cut.While bending the vitallium rod with the french bender the product broke in half on the back table about 2 inches in.During surgery while putting the rod in the screw the head fell off of the screw.The screw was already in the patient.All broken fragments retrieved.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
XIA PRECISION SCREW 7.5 X 55MM
Type of Device
PEDICLE SCREW SPINAL SYSTEM.
Manufacturer (Section D)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
-
la chaux-de-fonds 2300
CH  2300
Manufacturer (Section G)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
-
la chaux-de-fonds 2300
CH   2300
Manufacturer Contact
christa marrow
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key6498772
MDR Text Key73222778
Report Number3005525032-2017-00050
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07613154088942
UDI-Public(01)07613154088942
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number48231755
Device Catalogue Number48231755
Device Lot NumberA81887
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/10/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Weight159
-
-