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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL LEIBINGER MEIZINTECHNIK GMBH AND CO. KG MMF SCREW
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KARL LEIBINGER MEIZINTECHNIK GMBH AND CO. KG MMF SCREW Back to Search Results
Model Number 25-092-08-09
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/10/2014
Event Type  Injury  
Event Description
During implantation, the screw head broke off and the screw shaft still resides within the pt's maxilla.Doctor implant the screw into the pt's tooth root.
 
Manufacturer Narrative
Device is not available for eval.If further info is acquired that adds value to the content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
 
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Brand Name
MMF SCREW
Manufacturer (Section D)
KARL LEIBINGER MEIZINTECHNIK GMBH AND CO. KG
kolbinger str. 10
muhlheim/donau 7857 0
GM  78570
Manufacturer (Section G)
KARL LEIBINGER MEDIZINTECHNIK GMBH AND CO. KG
kolbinger str. 10
muhlheim/donau 7857 0
GM   78570
Manufacturer Contact
jennifer damato
po box 16369
jacksonville, FL 32245
9046417746
MDR Report Key4218570
MDR Text Key4973076
Report Number9610905-2014-00025
Device Sequence Number1
Product Code DZL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042573
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 10/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number25-092-08-09
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/10/2014
Was Device Evaluated by Manufacturer? No
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 Outcome(s) Other;
Patient Age22 YR
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