MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF POSTERIOR CAGE; SPINAL CAGE

Catalog Number 03.27.025

Device Problem Break (1069)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/14/2018

Event Type  Injury  

Manufacturer Narrative

Preliminary investigation performed by r&d spine director on 16 august 2018; the surgeon tried to implant a 28mm oblique cage that he considered as too long.Because of that he switched to a plif cage 9mm 10° 25mm long.The surgeon didn't use the trial as described in the surgical technique.Because of that he had to apply a lot of impaction force.In addition to that he applied a lot of bending forces in order to rotated the implant.The combination of a too large implant and the high impaction/bending forces must have caused the failure.The surgeon was at the end able to implant a new cage with the same size 9mm 10° 25mm without problem.Most likely the access portal to the disc space was increased in order to simplify the insertion of the cage.The use of the trials could have avoided the problem.Batch review performed on 12 september 2018; lot 1720966: (b)(4) items manufactured and released on 22 march 2018.Expiration date: 2023-03-11; no anomalies found related to the problem.To date, (b)(4) 8 items of the same lot have been already sold without any similar reported event.Visual inspection performed on 13 september 2018 by r&d product manager from the visual inspection of the mectalif posterior 03.27.025 (lot 1720966), it's possible to see that the implant is broken in two pieces.The breakage is probably due to the application of a huge medio-lateral force of the implant.

Event Description

The surgeon tried to insert the posterior cage obliquely because the patient's vertebral body was too small against the length of the cage.When the surgeon was inserting the posterior cage obliquely, the posterior cage was broken.The surgeon removed the broken posterior cage and inserted the backup posterior cage.

• Brand Name: MECTALIF POSTERIOR CAGE
• Type of Device: SPINAL CAGE
• 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: 7872483
• MDR Text Key: 120122238
• Report Number: 3005180920-2018-00676
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07630030831676
• UDI-Public: 07630030831676
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133192
• 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
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2023
• Device Catalogue Number: 03.27.025
• Device Lot Number: 1720966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2018
• 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