MAUDE Adverse Event Report: SYNTHES GMBH UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown arcofix/telefix/ventrofix: telefix implant/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that patient underwent osteosynthesis eight years ago due to an accident with an lwk 1 fracture.Since implantation, patient has been feeling discomfort.Patient also has constant pain in the affected area.Part of the implanted construct was removed in 2014.This report is for an unknown arcofix/telefix/ventrofix: telefix implant.This is report 3 of 6 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.D1, d2, d3, d4, g4-510k: this report is for an unknown telefix screw titan 7x40mm/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is for one (1) telefix screw titan 7x40mm.

• Brand Name: UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12177584
• MDR Text Key: 261831200
• Report Number: 8030965-2021-05812
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2021
• Patient Sequence Number: 1
• Treatment: UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX
• Patient Outcome(s): Required Intervention