MAUDE Adverse Event Report: ULRICH GMBH & CO. KG NEON3; SCREW, 3.5MM, LENGTH 18MM

Model Number	CS 3902-35-18
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/05/2016
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.
Event or Problem Description
Screw breakage.

• Brand Name: NEON3
• Common Device Name: SCREW, 3.5MM, LENGTH 18MM
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 5996463
• Report Number: 9612420-2016-00010
• Device Sequence Number: 570652
• Product Code: NKG
• UDI-Device Identifier: 04052536084210
• UDI-Public: 4052536084210
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2016

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 Number: CS 3902-35-18
• Device Catalogue Number: CS 3902-35-18
• Device Lot Number: U007382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2016
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/29/2016
• Device Age: 1 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2016
• Initial Report FDA Received Date: 10/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 80