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

Device Problem Material Fragmentation (1261)

Patient Problem Failure of Implant (1924)

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report is being submitted past 30 day deadline based on retrospective review conducted 6/27/2019.

Event 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
• Type of Device: 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
• Manufacturer (Section G): ULRICH GMBH & CO. KG; buchbrunnenweg 12; na; ulm, 89081 ; GM 89081
• Manufacturer Contact: christoph ulrich ; buchbrunnenweg 12; na; ulm, baden-württemberg 89081 ; GM 89081
• MDR Report Key: 8745577
• MDR Text Key: 149553148
• Report Number: 9612420-2019-00045
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 04052536002443
• UDI-Public: 4052536002443
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/21/2018,06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR