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

Catalog Number	03.27.025
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	08/14/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: SPINAL CAGE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7872483
• Report Number: 3005180920-2018-00676
• Device Sequence Number: 19272022
• Product Code: MAX
• UDI-Device Identifier: 07630030831676
• UDI-Public: 07630030831676
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2018

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other