MAUDE Adverse Event Report: BIEDERMANN MOTECH GMBH & CO. KG TELIX K TI CAGE, 9X28MM 5°

Model Number 109-015-0928

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2018

Event Type  Injury  

Manufacturer Narrative

Udi information not available.Primary device identifier: (b)(4).The device was not returned and the lot number is unknown, therefore a review of the dhr and inspection of the device is not possible.The manufacturer will be informed of this event and if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Inferior end plate fracture and a posterior shift of the subject device prompted revision surgery.There were no complications reported during the removal procedure.

• Brand Name: TELIX K TI CAGE, 9X28MM 5°
• Type of Device: TELIX K TI CAGE, 9X28MM 5°
• Manufacturer (Section D): BIEDERMANN MOTECH GMBH & CO. KG; bertha-von-suttner-strasse 23; 78054; villingen-schwenningen, ; GM
• MDR Report Key: 7399220
• MDR Text Key: 104451635
• Report Number: 3013248720-2018-00001
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2018,03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 109-015-0928
• Device Catalogue Number: 109-015-0928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2018
• Distributor Facility Aware Date: 03/06/2018
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR