MAUDE Adverse Event Report: AFT POLYAXIAL SCREW PERLA TL

Model Number TLF-PS 75 40-S

Device Problem Fracture (1260)

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

Event Date 10/03/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation ongoing.

Event Description

On october, 31, 2023, we received a complaint from the field (see (b)(4)) reporting a broken screw during a removal surgery (the patient needed to have an anterior interbody fixation.) the patient was operated on (b)(6) 2022 and the revision surgery was realized on october, 03, 2023.The broken screw (shank) was left inside the patient with no impact.We have been informed that the hospital submitted a mdr to the fda for this complaint.

Manufacturer Narrative

The manufacturing folder has been reviewed.Complained device belongs to a batch of 408 parts manufactured on 30.Sep.2021, 281 parts have been already implanted and this the first complaint we receive for this type of defect on this batch.The analysis on the manufacturing documents and control quality documents detected that raw materials and production processes were conforming to the specifications.This leads to the conclusion that what reported is not significant to blame a defect to the manufacturing process.We did not receive the broken implant.But the picture clearly shows that the screw is broken.Despite our several requests (mail of 26.Oct.2023 and 06.Nov.2023) we did not receive the implant and we had no more information about the breakage.We cannot explain what happened.Since the launch of the device, (b)(4) devices have been implanted and we received only 1 return from the field reporting a breakage issue on this range of products, which represents 0,002% of issue.The rate is very low, this is an isolated case.We close the case as is.

Event Description

On october, 31, 2023, we received a complaint from the field (see (b)(4)) reporting a broken screw during a removal surgery (the patient needed to have an anterior interbody fixation.The patient was operated on (b)(6) 2022 and the revision surgery was realized on (b)(6) 2023.The broken screw (shank) was left inside the patient with no impact.We have been informed that the hospital submitted a mdr to the fda for this complaint.

• Brand Name: POLYAXIAL SCREW PERLA TL
• Type of Device: POLYAXIAL SCREW PERLA TL
• Manufacturer (Section D): AFT
• Manufacturer Contact: laure-allison verboux ; chemin du pré fleuri 3; plan-les-ouates, geneva 1228 ; SZ 1228
• MDR Report Key: 18037799
• MDR Text Key: 327635242
• Report Number: 3007728266-2023-00007
• 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
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TLF-PS 75 40-S
• Device Catalogue Number: TLF-PS 75 40-S
• Device Lot Number: 5-8650
• Was Device Available for Evaluation?: No
• 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
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Female