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: SYNTHES (USA) PRODUCTS LLC TITANIUM CORTEX SCREW; SCREW, FIXATION, INTRAOSSEOUS
  • 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
 

SYNTHES (USA) PRODUCTS LLC TITANIUM CORTEX SCREW; SCREW, FIXATION, INTRAOSSEOUS Back to Search Results
Catalog Number 401.046
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/17/2016
Event Type  malfunction  
Event Description
Screw head removed, shaft broke off and could not be removed due to the scar tissue.Surgeon shaved down the shaft with the drill to smooth the shaft so it would not protrude through the tissue.Case was a hardware removal of a titanium screw.It is common when removing titanium screws for them to shear off.In this case, the screw was being removed from a mandible and the screws are small.It is then up to the surgeon to decide risk vs benefit of trying to remove the retained screw shaft.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TITANIUM CORTEX SCREW
Type of Device
SCREW, FIXATION, INTRAOSSEOUS
Manufacturer (Section D)
SYNTHES (USA) PRODUCTS LLC
1303 goshen pkwy.
west chester PA 19380
MDR Report Key6099295
MDR Text Key59771489
Report Number6099295
Device Sequence Number1
Product Code DZL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/19/2016
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 No Information
Device Catalogue Number401.046
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/19/2016
Event Location Hospital
Date Report to Manufacturer09/19/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age65 YR
-
-