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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; LOCKING SCREW
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ULRICH GMBH & CO. KG UCENTUM; LOCKING SCREW Back to Search Results
Model Number CS 3801-01
Medical Device Problem Codes Material Separation (1562); Unintended Movement (3026)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 01/31/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Ulrich medical gmbh (manufacturer) is submitting this report for both ulrich medical gmbh and ulrich medical usa (importer) exemption # e2014011.
 
Event or Problem Description
Two locking screws separated postoperatively from the pedicle screws and a revision was done to replace the locking screws.
 
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Brand Name
UCENTUM
Common Device Name
LOCKING SCREW
Manufacturer (Section D)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, 89081
GM  89081
MDR Report Key7381524
Report Number9612420-2018-00001
Device Sequence Number1392893
Product Code NKB
UDI-Device Identifier04052536078646
UDI-Public4052536078646
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K123717
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
Report Date (Section B) 03/28/2018
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 No Information
Device Model NumberCS 3801-01
Device Catalogue NumberCS 3801-01
Device Lot NumberU014000 & U014001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/06/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/08/2018
Initial Report FDA Received Date03/29/2018
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 Hospitalization; Required Intervention;
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