MAUDE Adverse Event Report: ULRICH GMBH & CO. KG NEON3; ROD REDUCTION INSTRUMENT

Model Number	CS 3938-06
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A revision was done (b)(6) as a result of screws backing out.During the revision when they were trying to replace a rod the rod reducer broke.Report 4 of 5.

• Brand Name: NEON3
• Common Device Name: ROD REDUCTION INSTRUMENT
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 9897257
• Report Number: 9612420-2020-00007
• Device Sequence Number: 16841277
• Product Code: KWP
• UDI-Device Identifier: 04052536170029
• UDI-Public: 4052536170029
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: CS 3938-06
• Device Catalogue Number: CS 3938-06
• Device Lot Number: BEA1958451116
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 03/30/2020
• 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: Hospitalization
• Patient Age: 69 YR