MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ACDF MECTA-C SA TIPEEK CAGE 18X15X7X7°; SPINE INTERVERTEBRAL CAGE

Catalog Number 03.18.119

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/27/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 21 january 2022: lot 1923914: (b)(4) items manufactured and released on 12-may-2020.Expiration date: 2025-04-26.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.Visual inspection performed by spine r&d project manager: four mecta-c stand alone cages have been used to stabilize c3-c7 and after one year fixation is deemed not sufficient, so the cages are removed.After the visual inspection no critical issues are noted: the implants are not broken and did not fail mechanically.There are scratches visible on the implants but they could be related to the removal surgery.Clinical evaluation performed by medacta medical affairs director: 4 standalone cervical cages have been used to stabilize c3-c7 and after one year fixation is deemed not sufficient, so the cages are removed.They are not broken and did not fail mechanically, but the patient did not achieve fusion.According to report, it's probable that patient cooperation hasn't been optimal.In such a long construct, often posterior fixation is also sought to supplement the cages, but the primary surgeon decided otherwise.The long construct is naturally challenging, although it is not outside of the product indications.A very cooperative patient is certainly helpful to get a good result in a challenging case.

Event Description

The patient was revised about 1 year after the primary surgery (primary surgery date is unknown, probably in (b)(6) 2020).Explantation of 4 mecta-c sa implants on c3-c7 and replaced with competitor component.An additional posterior tension band was performed.The surgeon does not think that there is any implant failure of medacta, but a suboptimal strategy to perform the initial surgery (using 4 mecta-c sa is not the right way in the surgeon's opinion, but cage and plate would be the best way, combined with posterior tension band as described above, if necessary).

• Brand Name: ACDF MECTA-C SA TIPEEK CAGE 18X15X7X7°
• Type of Device: SPINE INTERVERTEBRAL CAGE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13356856
• MDR Text Key: 284443044
• Report Number: 3005180920-2022-00035
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K192906
• 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: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03.18.119
• Device Lot Number: 1923914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Date Manufacturer Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2020
• 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): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male