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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG LEVEL ONE CMF; PLATE
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KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG LEVEL ONE CMF; PLATE Back to Search Results
Model Number 01-100-36-09
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Impaired Healing (2378)
Date of Event 09/30/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The failure root cause cannot be determined due to the device not being returned.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.
 
Event or Problem Description
It was reported a plate broke due to patient noncompliance and was removed.
 
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Brand Name
LEVEL ONE CMF
Common Device Name
PLATE
Manufacturer (Section D)
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
kolbinger strasse 10
muehlheim/donau, 78570
GM  78570
MDR Report Key10683431
Report Number9610905-2020-00112
Device Sequence Number2954896
Product Code JEY
UDI-Device Identifier00888118004840
UDI-Public(01)00888118004840
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
PMA/510(K) Number
K943347
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number01-100-36-09
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/30/2020
Initial Report FDA Received Date10/15/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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