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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; SET SCREW
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ULRICH GMBH & CO. KG UCENTUM; SET SCREW Back to Search Results
Model Number CS 3801-01
Medical Device Problem Code Device Handling Problem (3265)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 11/29/2018
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.Report is being submitted past 30 day deadline based on retrospective review conducted on 6/21/2019.Original mdr (report 1 of 4) filed 12/26/2018.
 
Event or Problem Description
Set screws would not engage the pedicle screw.Report 4/4.
 
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Brand Name
UCENTUM
Common Device Name
SET SCREW
Manufacturer (Section D)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, 89081
GM  89081
MDR Report Key8745569
Report Number9612420-2019-00035
Device Sequence Number1680729
Product Code NKB
UDI-Device Identifier04052536078646
UDI-Public4052536078646
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K123717
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/25/2019
Report Date (Section F) 12/12/2018
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 Health Professional
Device Model NumberCS 3801-01
Device Catalogue NumberCS 3801-01
Device Lot NumberU019563
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/29/2018
Date Report to Manufacturer12/12/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/12/2018
Initial Report FDA Received Date06/28/2019
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 Hospitalization;
Patient Age69 YR
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