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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; SCREW
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KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG LEVEL ONE CMF; SCREW Back to Search Results
Model Number 25-878-05-91
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Impaired Healing (2378)
Date of Event 11/14/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.Multiple mdr reports were filed for this event, please see associated report: 9610905-2019-00251.
 
Event or Problem Description
It was reported screws securing a plate were removed due to the patient having trouble with eye mobility unrelated to the implants.
 
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Brand Name
LEVEL ONE CMF
Common Device Name
SCREW
Manufacturer (Section D)
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
kolbinger strasse 10
muehlheim/donau, 78570
GM  78570
MDR Report Key9477035
Report Number9610905-2019-00252
Device Sequence Number2648559
Product Code HRS
UDI-Device Identifier00888118047694
UDI-Public(01)00888118047694
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K971297
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/14/2019
Report Date (Section F) 11/14/2019
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 Number25-878-05-91
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date11/14/2019
Event Location Hospital
Date Report to Manufacturer11/14/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/14/2019
Initial Report FDA Received Date12/16/2019
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 Age78 YR
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