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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIEDERMANN MOTECH GMBH & CO. KG TAP 5.0MM, LIGHT BLUE DL, 1/4" COUPLING, LIGHT BLUE; TAP Ø5.0MM, LIGHT BLUE DL, 1/4" COUPLING, LIGHT BLUE
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BIEDERMANN MOTECH GMBH & CO. KG TAP 5.0MM, LIGHT BLUE DL, 1/4" COUPLING, LIGHT BLUE; TAP Ø5.0MM, LIGHT BLUE DL, 1/4" COUPLING, LIGHT BLUE Back to Search Results
Model Number 208-040-0409
Device Problem Fracture (1260)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/05/2019
Event Type  Injury  
Manufacturer Narrative
Visual inspection confirmed the reported complaint.At the moment this is considered an isolated incident.The manufacturer will be informed of this complaint and the device will be shipped for further investigation.If additional information becomes available, a follow-up medwatch report will be submitted.
 
Event Description
It has been reported verbally that the subject device broke when tapping the thread in the sacrum.The tip of the subject device could not be removed and was left in the bone.Surgery was resumed and the implantation procedure was completed with no other reports of patient impacts.
 
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Brand Name
TAP 5.0MM, LIGHT BLUE DL, 1/4" COUPLING, LIGHT BLUE
Type of Device
TAP Ø5.0MM, LIGHT BLUE DL, 1/4" COUPLING, LIGHT BLUE
Manufacturer (Section D)
BIEDERMANN MOTECH GMBH & CO. KG
bertha-von-suttner-strasse 23
villingen-schwenningen, 78054
GM  78054
MDR Report Key8713537
MDR Text Key148463875
Report Number3013248720-2019-00001
Device Sequence Number1
Product Code NKB
UDI-Device Identifier04250869634472
UDI-Public(01)04250869634472(10)BDM5TST
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/18/2019,06/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number208-040-0409
Device Catalogue Number208-040-0409
Device Lot NumberBDM5TST
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2019
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/18/2019
Distributor Facility Aware Date06/11/2019
Event Location Hospital
Date Report to Manufacturer06/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age69 YR
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