MAUDE Adverse Event Report: POLYAXIAL SCREW

Model Number TLF-PS 85 90-S

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is currently ongoing.We are waiting for the device back for inspection.

Event Description

On november, 17, 2023, we received a complaint (see cpt-2643 folder) reporting that, during a plan hardware removal on (b)(6) 2023, the surgeon found a screw dislocation.He completed the surgery with no impact on the patient, with a surfery delay of less than 30 minutes.

Event Description

On november, 17, 2023, we received a complaint (see cpt-2643 folder) reporting that, during a plan hardware removal on (b)(6) 2023, the surgeon found a screw dislocation.He completed the surgery with no impact on the patient, with a surfery delay of less than 30 minutes.

Manufacturer Narrative

After we received the complaint, the manufacturing folder has been reviewed.Complained device belongs to a batch of 40 parts manufactured in june 2022 and (b)(4)screws have already been implanted with no issue and this is the first complaint we receive for this type of defect for this batch.The analysis on the manufacturing documents and control quality documents detected that raw materials and production processes were conforming to the specifications.We were informed that the hardware removal was planned because of hadware loosening and that the screw dissociated was found before the removal thru x-rays taken prior to the removal.We did not receive the device because it has been scrapped.We received a picture showing that the head and the bone screw are dissociated.Despite our requests, no operative picture is available, and we could not inspect the device because it was scrapped at the hospital.Based on the above information, we can neither investigate nor explain what happened.We close the case as is with no further action.Nevertheless, regarding the increasing number of complaints reporting dislocation issues, r&d team performed some tests and reproduced this dislocation, in extreme conditions.It has been decided to open a pcr (b)(4) in order to modify the drawing of the head to avoid any other dislocation.Complained device belongs to the batch 6-9251, which has been manufactured before the implementation of the pcr.

• Brand Name: POLYAXIAL SCREW
• Type of Device: POLYAXIAL SCREW
• Manufacturer Contact: laure-allison verboux ; chemin du pré fleuri 3; plan les ouates, geneva 1228 ; SZ 1228
• MDR Report Key: 18324550
• MDR Text Key: 330482503
• Report Number: 3007728266-2023-00010
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2024

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 Model Number: TLF-PS 85 90-S
• Device Catalogue Number: TLF-PS 85 90-S
• Device Lot Number: 6-9251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1