MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X28X11 L10°

Catalog Number	03.26.051
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 05 january 2018: (b)(4).Visual inspection performed by r and d product manager on 08 january 2018: the cage received back from the field (ref.03.26.051 lot 146278) has the m4 thread damaged.The functionality of the implant is compromised and it's not possible to engage the implant in the correct position (straight).The damaging is probably due to crossthreading of between the inner shaft of the inserter and the implant itself.
Event or Problem Description
During the surgery it was not possible for the surgeon to correctly engage the cage to the driver.The surgery was completed successfully using a new cage of the same size.

• Brand Name: MECTALIF OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X28X11 L10°
• Common Device Name: INTERBODY FUSION DEVICE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7178497
• Report Number: 3005180920-2017-00821
• Device Sequence Number: 1212108
• Product Code: MAX
• UDI-Device Identifier: 07630030830709
• UDI-Public: 07630030830709
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/10/2018

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: 06/01/2020
• Device Catalogue Number: 03.26.051
• Device Lot Number: 146278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 01/10/2018
• 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