MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; INNER SLEEVE FOR ROD PUSHER, OPEN

Model Number CS 3838-02

Device Problem Material Fragmentation (1261)

Patient Problem Failure of Implant (1924)

Event Date 01/12/2017

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

Rod pusher inner sleeve ("persuader") malfunction caused screw to break during insertion.

• Brand Name: UCENTUM
• Type of Device: INNER SLEEVE FOR ROD PUSHER, OPEN
• 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: 8745576
• MDR Text Key: 149553254
• Report Number: 9612420-2019-00041
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04052536081448
• UDI-Public: 4052536081448
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123717
• 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: 01/12/2017,06/27/2019

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 3838-02
• Device Catalogue Number: CS 3838-02
• Device Lot Number: WSA14727344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/12/2017
• Date Report to Manufacturer: 01/12/2017
• Date Manufacturer Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization