MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; SCREW, POLYAXIAL, 6.5MM, LENGTH 50MM

Model Number	CS 3802-065-050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/06/2016
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: UCENTUM
• Common Device Name: SCREW, POLYAXIAL, 6.5MM, LENGTH 50MM
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 5999870
• Report Number: 9612420-2016-00013
• Device Sequence Number: 703968
• Product Code: NKB
• UDI-Device Identifier: 04052536078844
• UDI-Public: 4052536078844
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123717
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/05/2016

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 3802-065-050
• Device Catalogue Number: CS 3802-065-050
• Device Lot Number: U005518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/05/2016
• Device Age: 4 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2016
• Initial Report FDA Received Date: 10/05/2016
• 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: 62 YR
• Patient Weight: 109