MAUDE Adverse Event Report: BIEDERMANN MOTECH GMBH & CO. KG TELIX K; TELIX K TI CAGE 14X36MM 5°

Model Number	109-015-1436
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	12/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via phone call to bmus on 12-16-2021, that a revision surgery was needed to replace previously implanted interbody cage ((b)(6) 2021).Patient had complained about discomfort, and it was found the implant had rotated and migrated from original position.There are no reports of delays or impact on the patients outcome as a result of the revision surgery.Subject item will not be returned.The revision surgery included removing the 14mm cage and replacing it with a 15mm cage.
Event or Problem Description
It was reported via phone call to bmus on 12-16-2021, that a revision surgery was needed to replace previously implanted interbody cage ((b)(6) 2021).Patient had complained about discomfort, and it was found the implant had rotated and migrated from original position.There are no reports of delays or impact on the patients outcome as a result of the revision surgery.Subject item will not be returned.The revision surgery included removing the 14mm cage and replacing it with a 15mm cage.

• Brand Name: TELIX K
• Common Device Name: TELIX K TI CAGE 14X36MM 5°
• Manufacturer (Section D): BIEDERMANN MOTECH GMBH & CO. KG; bertha-von-suttner str.23; villingen-schwenningen 78054 ; GM 78054
• Manufacturer Contact: gerd federle ; bertha-von-suttner str. 23; villingen-schwenningen, 78054 ; GM 78054
• MDR Report Key: 13321792
• Report Number: 8010944-2022-00001
• Device Sequence Number: 11174448
• Product Code: MAX
• UDI-Device Identifier: 04250869607841
• UDI-Public: 04250869607841
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 109-015-1436
• Device Catalogue Number: 109-015-1436
• Device Lot Number: INFORMATION NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male