MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; LOCKING SCREW

Model Number CS 3801-01

Device Problems Detachment Of Device Component (1104); Material Separation (1562); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The locking set screw looked to be sitting off the top left screw in a follow up mri.A revision surgery was conducted revealing that the set screw was in fact out of the head of the screw.Both the set screw and screw were explanted and discarded by the hospital.

• Brand Name: UCENTUM
• Type of Device: LOCKING SCREW
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• Manufacturer (Section G): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• Manufacturer Contact: christoph ulrich ; buchrunnenweg 12; ulm, 89081 ; GM 89081 ; 7319654 16
• MDR Report Key: 6388916
• MDR Text Key: 69443952
• Report Number: 9612420-2017-00006
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04052536078646
• UDI-Public: 4052536078646
• 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,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/08/2017

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?: Yes
• Device Operator: No Information
• Device Model Number: CS 3801-01
• Device Catalogue Number: CS 3801-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/06/2017
• Initial Date Manufacturer Received: 02/08/2017
• Initial Date FDA Received: 03/08/2017
• 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): Required Intervention
• Patient Weight: 136