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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH GMBH & CO. KG OBELISC; LATERAL END PIECE
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ULRICH GMBH & CO. KG OBELISC; LATERAL END PIECE Back to Search Results
Model Number CS 2916-05
Medical Device Problem Codes Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Codes Failure of Implant (1924); Injury (2348)
Date of Event 08/06/2018
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
X-rays one week post op revealed one end plate had detached from the cage and the construct had migrated.Revision was done to replace plate and reposition construct.
 
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Brand Name
OBELISC
Common Device Name
LATERAL END PIECE
Manufacturer (Section D)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, baden-württemberg 89081
GM  89081
MDR Report Key7826165
Report Number9612420-2018-00013
Device Sequence Number1175262
Product Code MQP
UDI-Device Identifier04052536113798
UDI-Public4052536113798
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K060416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/28/2018
Report Date (Section F) 08/13/2018
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 2916-05
Device Catalogue NumberCS 2916-05
Device Lot NumberU014322
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/06/2018
Event Location Hospital
Date Report to Manufacturer08/13/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/13/2018
Initial Report FDA Received Date08/29/2018
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 Required Intervention;
Patient Age61 YR
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