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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA LOCKSCR Ø3.5 SELF-TAP L18 TAN
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SYNTHES USA LOCKSCR Ø3.5 SELF-TAP L18 TAN Back to Search Results
Catalog Number 413.018
Device Problems Partial Blockage (1065); Failure to Disconnect (2541)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/15/2013
Event Type  malfunction  
Event Description
Device report from synthes (b)(4) reports an event in (b)(6) as follows: during a removal osteosynthesis surgery, it was impossible to unscrew the screws of the plate (screws blocked).The screw heads were destroyed with a drill in order to remove the plate.There was an extension of delay of surgery.Fragments remain in the soft tissue.No clinical consequence in intraoperative.This is report 4 of 4 for complaint (b)(4).
 
Manufacturer Narrative
Device was used for treatment, not diagnosis.Date of implant unknown.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number was provided.Placeholder.
 
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Brand Name
LOCKSCR Ø3.5 SELF-TAP L18 TAN
Manufacturer (Section D)
SYNTHES USA
west chester PA
Manufacturer Contact
w. lindenmuth
1302 wrights lane east
west chester, PA 19380
8006207025
MDR Report Key3595231
MDR Text Key4168461
Report Number2520274-2014-00332
Device Sequence Number1
Product Code KTT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K000684
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number413.018
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/08/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Patient Sequence Number1
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