MAUDE Adverse Event Report: ULRICH MEDICAL GMBH & CO. KG NEON3; OCCIPUTAL PLATE, LATERAL, WITH ROD

Model Number	CS 3913-05
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
After the implantation of the two oc plates with rods, the rods broke insitu after approx.2 months.Report 1 of 2.

• Brand Name: NEON3
• Common Device Name: OCCIPUTAL PLATE, LATERAL, WITH ROD
• Manufacturer (Section D): ULRICH MEDICAL GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 11311368
• Report Number: 9612420-2021-00002
• Device Sequence Number: 19760964
• Product Code: NKG
• UDI-Device Identifier: 04052536161454
• UDI-Public: 04052536161454
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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 Number: CS 3913-05
• Device Catalogue Number: CS 3913-05
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 10/29/2021
• 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