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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH GMBH & CO. KG ADDPLUS; OSMIUM SCREW
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ULRICH GMBH & CO. KG ADDPLUS; OSMIUM SCREW Back to Search Results
Model Number CS 1300-14T
Medical Device Problem Codes Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 02/07/2019
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 superior screws to be backing out and cage to be tilting away from intended position.
 
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Brand Name
ADDPLUS
Common Device Name
OSMIUM SCREW
Manufacturer (Section D)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, baden-württemberg 89081
GM  89081
MDR Report Key8343493
Report Number9612420-2019-00003
Device Sequence Number2418908
Product Code MQP
UDI-Device Identifier04052536002436
UDI-Public4052536002436
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K090841
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/15/2019
Report Date (Section F) 02/14/2019
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 1300-14T
Device Catalogue NumberCS 1300-14T
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/07/2019
Event Location Hospital
Date Report to Manufacturer02/14/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/14/2019
Initial Report FDA Received Date02/15/2019
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 Required Intervention;
Patient Age60 YR
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