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 SLIDE TRIAL HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  • 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 SLIDE TRIAL HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number 48361234
Medical Device Problem Codes Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/14/2017
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that; while i was putting sets back together to go back up for a case, i noticed that the trial handle was missing its tip and there was also a solid trial with a tip broken off in it.
 
Event or Problem Description
It was reported that; while i was putting sets back together to go back up for a case, i noticed that the trial handle was missing its tip and there was also a solid trial with a tip broken off in it.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SLIDE TRIAL HANDLE
Common Device Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR  33610
MDR Report Key6694608
Report Number0009617544-2017-00278
Device Sequence Number19224038
Product Code LXH
UDI-Device Identifier07613327269147
UDI-Public(01)07613327269147
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 08/31/2017
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
Operator of Device No Information
Device Model Number48361234
Device Catalogue Number48361234
Device Lot Number13C526
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2017
Initial Date Received by Manufacturer 06/14/2017
Supplement Date Received by Manufacturer06/14/2017
Initial Report FDA Received Date07/07/2017
Supplement Report FDA Received Date08/31/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-