MAUDE Adverse Event Report: EIT EMERGING IMPLANT TECHNOLOGIES GMBH TRIAL INSERTER SH CONNECTION; INTERVERTEBRAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Model Number TFT20101

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A review of the receiving inspection (ri) for trial inserter sh connection was conducted identifying that lot number e19di0730 was released in a single batch.Batch1: released on march 27, 2016 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Complaint summary: at the start of the above procedure, the insert for the trial inserter sh connection (tft20101) appeared bent, and was tagged for repair.The instrument(s) was not returned, and instead, the investigation will be done based on the received image(s).The image(s) was reviewed, and the complaint condition could be confirmed as the distal tip looks bent.As the instrument(s) was not returned, an as received condition, dimensional inspection, material, or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation, no product design issues, or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending, and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective, and/or preventative action is proposed.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

Device report from (b)(6) reports an event as follows: it was reported that at the start of an l4/5 posterior lumbar interbody fusion (plif), the insert for the trial inserter sh connection appeared bent, and was tagged for repair.The second inserter was used off the set.Procedure was completed successfully with no delay.There was no patient consequence.This report is for a trial inserter sh connection.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

H10 additional narrative: h4: updated manufacturing date 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.

• Brand Name: TRIAL INSERTER SH CONNECTION
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen D-785 73
• MDR Report Key: 10662089
• MDR Text Key: 214154636
• Report Number: 3013730328-2020-00026
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 04260557775578
• UDI-Public: (01)04260557775578
• Combination Product (y/n): N
• PMA/PMN Number: K172888
• 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: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TFT20101
• Device Catalogue Number: TFT20101
• Device Lot Number: E19DI0730
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/12/2020
• Supplement Dates Manufacturer Received: 10/26/2020
• Supplement Dates FDA Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR