MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR STAND-ALONE (TIPEEK); INTERVERTEBRAL CAGE

Device Problem Use of Device Problem (1670)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/19/2020

Event Type  Injury  

Manufacturer Narrative

No document review is possible since the lot number is not available.

Event Description

The surgeon has raised a concern via text message and confirmed this concern verbally via telephone in relation a "few" of his patients exhibiting a sacral fracture 6-8 weeks post-operatively in their l5/s1 alif using the mectalif anterior tipeek.All cages used were of the flush design plate.The surgeon has completed 13 alif procedures using the mectalif anterior, with 10 at l5/s1.He has also indicated that a colleague of precision brain & spine has noticed the same issue with a patient.He has completed one mectalif anterior tipeek.At this stage both surgeons have not provided any further details.

• Brand Name: MECTALIF ANTERIOR STAND-ALONE (TIPEEK)
• Type of Device: 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: 10166696
• MDR Text Key: 195904389
• Report Number: 3005180920-2020-00338
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2020
• Was Device Evaluated by Manufacturer?: No
• 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