MAUDE Adverse Event Report: ULRICH GMBH & CO. KG ADDPLUS; CAGE, Ø 12 MM, HEIGHT 25-41 MM, ANGLE 12°

Model Number CS 2253-12-25

Device Problems Material Fragmentation (1261); Difficult to Insert (1316)

Patient Problem Failure of Implant (1924)

Event Date 12/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The surgeon was unable to drive in the set screw.The rep reported that the threads on the device appeared stripped and metal particles were coming off of the screw and cage.The cage was implanted with no locking screw.

• Brand Name: ADDPLUS
• Type of Device: CAGE, Ø 12 MM, HEIGHT 25-41 MM, ANGLE 12°
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, baden-württemberg 89081 ; GM 89081
• Manufacturer (Section G): ULRICH GMBH & CO. KG; buchbrunnenweg 12; na; ulm, baden-württemberg 89081 ; GM 89081
• Manufacturer Contact: christoph ulrich ; buchbrunnenweg 12; na; ulm, baden-württemberg 89081 ; GM 89081
• MDR Report Key: 8256507
• MDR Text Key: 133340462
• Report Number: 9612420-2019-00001
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 04052536009374
• UDI-Public: 4052536009374
• 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: 01/10/2019,01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CS 2253-12-25
• Device Catalogue Number: CS 2253-12-25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2019
• Date Manufacturer Received: 01/10/2019
• 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: 57 YR