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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG LEVEL ONE THORACIC; PLATE
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KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG LEVEL ONE THORACIC; PLATE Back to Search Results
Model Number 24-015-32-71
Medical Device Problem Codes Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Impaired Healing (2378)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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 the patient fell and the plates broke as a result of the fall and necessitated removal of the plates.
 
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Brand Name
LEVEL ONE THORACIC
Common Device Name
PLATE
Manufacturer (Section D)
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
kolbinger strasse 10
muehlheim/donau, 78570
GM  78570
MDR Report Key12028686
Report Number9610905-2021-00051
Device Sequence Number3674167
Product Code HRS
UDI-Device Identifier00888118121264
UDI-Public(01)00888118121264
Combination Product (Y/N)Y
Initial Reporter StateNH
Initial Reporter CountryUS
PMA/510(K) Number
K153482
Exemption Number2017029
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
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) 05/20/2021
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 Number24-015-32-71
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/20/2021
Initial Report FDA Received Date06/18/2021
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;
Patient Age60 YR
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