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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG LEVEL ONE NEURO; SCREW
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KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG LEVEL ONE NEURO; SCREW Back to Search Results
Model Number 25-975-04-91
Medical Device Problem Codes Device Issue (2379); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Impaired Healing (2378)
Date of Event 03/19/2018
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: mdr 9610905-2018-00052, mdr 9610905-2018-00053.
 
Event or Problem Description
It was reported that after the patient received radiation the screw may have backed out and needs to be removed and replaced.Expected removal date (b)(6) 2018.
 
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Brand Name
LEVEL ONE NEURO
Common Device Name
SCREW
Manufacturer (Section D)
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
kolbinger strabe 10
muhlheim/donau, 78570
GM  78570
MDR Report Key7506050
Report Number9610905-2018-00054
Device Sequence Number217817
Product Code HRS
UDI-Device Identifier00888118048776
UDI-Public(01)00888118048776
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K971297
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 04/16/2018
Report Date (Section F) 04/16/2018
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 Physician
Device Model Number25-975-04-91
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date04/16/2018
Event Location Hospital
Date Report to Manufacturer04/16/2018
Initial Date Received by Manufacturer 04/16/2018
Supplement Date Received by Manufacturer06/27/2018
Initial Report FDA Received Date05/11/2018
Supplement Report FDA Received Date07/25/2018
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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