MAUDE Adverse Event Report: ULRICH GMBH & CO. KG ADDPLUS; OSMIUM SCREW INCL. BOLT, GREEN, Ø 5.0 MM, LENGTH 16 MM

Model Number	CS 1300-16T
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/07/2018
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.Report is being submitted past 30 day deadline based on retrospective review conducted 6/27/2019.
Event or Problem Description
Osmium screw bolt broke off at top of head during initial surgery.The threaded portion remained in the shaft of the screw and the broken head was retrieved.

• Brand Name: ADDPLUS
• Common Device Name: OSMIUM SCREW INCL. BOLT, GREEN, Ø 5.0 MM, LENGTH 16 MM
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 8745577
• Report Number: 9612420-2019-00045
• Device Sequence Number: 11422567
• Product Code: MQP
• UDI-Device Identifier: 04052536002443
• UDI-Public: 4052536002443
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2019
• Report Date (Section F): 12/21/2018

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: Health Professional
• Device Model Number: CS 1300-16T
• Device Catalogue Number: CS 1300-16T
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/07/2018
• Date Report to Manufacturer: 12/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 06/28/2019
• 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: 61 YR