MAUDE Adverse Event Report: ULRICH GMBH & CO. KG NEON3 UNIVERSAL OCT SPINAL STABILIZATION; SCREW, CANNULATED, 4.0MM, LENGTH 32MM

Model Number	CS 3906-40-32
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
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 6 months post op revealed 2 broken screws between c2 and c7.A revision was done and one screw was returned to ulrich medical (b)(4), one was retained by the patient.

• Brand Name: NEON3 UNIVERSAL OCT SPINAL STABILIZATION
• Common Device Name: SCREW, CANNULATED, 4.0MM, LENGTH 32MM
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, baden-württemberg 89081 ; GM 89081
• MDR Report Key: 7683590
• Report Number: 9612420-2018-00011
• Device Sequence Number: 16493573
• Product Code: NKG
• UDI-Device Identifier: 04052536084500
• UDI-Public: 4052536084500
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2018

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 Number: CS 3906-40-32
• Device Catalogue Number: CS 3906-40-32
• Device Lot Number: U011998
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 07/12/2018
• 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