MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 ENHANCED

Catalog Number 03.30.132

Device Problem Break (1069)

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

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation performed by vice president spine division row on 22 august 2018 analysing this case we came to the following observations; the post-op picture showed a clear gap between the cage and the upper endplate of s1 - this could be caused either by selecting the wrong cage angulation (5,10,15 and 20 degrees options) which means the surgeon has to be way more careful using the cage templates and selecting the right kyphosis, or another possibility is that the surgeon did not do the right preparations before going with the screw inside the bone and basically created the gap pushing the s1 bone to the front while placing the screw.Independent from the scenario, the result was that this patient left the operating theatre with an alif implant that showed no contact with the s1 endplate.It is logical that the patients load (once he/she started to walk) caused this screw to break.Batch review performed on 18 september 2018.Lot 1720418: (b)(4) items manufactured and released on 22 november 2017 expiration date: 2022-11-02 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Other device involved.Mectalif anterior stand-alone screw diam.5x30 enhanced (double packaging) reference 03.30.132 (k160605) lot 1720419: (b)(4) items manufactured and released on 25 january 2018.Expiration date: 2023-01-14 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director on 20 september 2018 fracture of both s1 screws in a l5-s1 anterior fusion.According to surgeon's report, fusion is proceeding correctly and the broken screws did not limit recovery.No drill of tap was used, probably for reasons of speed.We cannot draw any definitive conclusions as to the effect that this variation of the recommended operative technique may have had but it is conceivable that it was influential in a potential weakening of the screws at the time of insertion.No clinical consequence should be expected at the present status because of the broken screws.

Event Description

The patient complained of back pain on (b)(6) 2018 and was sent for x-rays (l5/s1 alif procedure).This showed both s1 screws had broken.The surgeon has decided not to revise this and also to change his technique to include drilling and also more x-rays during procedure to ensure no gap.He is satisfied that the cage is fusing well and that the pain is not coming from this.

• Brand Name: MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 ENHANCED
• Type of Device: SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7893365
• MDR Text Key: 121569589
• Report Number: 3005180920-2018-00703
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 07630030875427
• UDI-Public: 07630030875427
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K160605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/20/2018

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 Expiration Date: 11/02/2022
• Device Catalogue Number: 03.30.132
• Device Lot Number: 1720418
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/22/2017
• Is the Device Single Use?: Yes
• 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: 54 YR