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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH GMBH & CO. KG NEON3; SCREW
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ULRICH GMBH & CO. KG NEON3; SCREW Back to Search Results
Model Number CS 3902-35-14
Medical Device Problem Code Break (1069)
Health Effect - Clinical Codes No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event 08/22/2018
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
Lateral mass screw was inserted as per standard technique (pre-drilling).As the screw was driven into the bone, the screw shank broke away from the head of the screw.The screw shank remained in the patient.The remains of the screw were returned.
 
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Brand Name
NEON3
Common Device Name
SCREW
Manufacturer (Section D)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, baden-württemberg 89081
GM  89081
MDR Report Key7904266
Report Number9612420-2018-00015
Device Sequence Number1395145
Product Code NKG
UDI-Device Identifier04052536084197
UDI-Public4052536084197
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K150650
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 09/24/2018
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 3902-35-14
Device Catalogue NumberCS 3902-35-14
Device Lot NumberU019719
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/13/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/01/2018
Initial Report FDA Received Date09/24/2018
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;
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