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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; CROSSLINK VARIABLE, MEDIUM
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ULRICH GMBH & CO. KG UCENTUM; CROSSLINK VARIABLE, MEDIUM Back to Search Results
Model Number CS 3810-03
Medical Device Problem Code Material Fragmentation (1261)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 05/23/2018
Type of Reportable Event Malfunction
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 6/27/2019.
 
Event or Problem Description
A piece of the cross connector broke when the surgeon was trying to place it over the rod in situ.
 
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Brand Name
UCENTUM
Common Device Name
CROSSLINK VARIABLE, MEDIUM
Manufacturer (Section D)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, 89081
GM  89081
MDR Report Key8745580
Report Number9612420-2019-00042
Device Sequence Number11422572
Product Code NKB
UDI-Device Identifier04052536080878
UDI-Public4052536080878
Combination Product (Y/N)N
Initial Reporter StateMO
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 Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/28/2019
Report Date (Section F) 05/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberCS 3810-03
Device Catalogue NumberCS 3810-03
Device Lot NumberWSA14727267
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/29/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/23/2018
Date Report to Manufacturer05/29/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/29/2018
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;
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