MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI

Catalog Number	03.27.001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on (b)(4) 2018: lot 1720591: (b)(4) items manufactured and released on 02 november 2017.Expiration date: 2022-10-10 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.Others devices involved.Mectalif posterior (ti peek) posterior interbody fusion device peek/ti 11x25x7 l0° reference (b)(4) (k133192) lot 143917: (b)(4) items manufactured and released on 10 october 2015.Expiration date: 2020-09-14 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.Mectalif offset inserter - inner shaft reference (b)(4) lot 1753707: (b)(4) items manufactured and released on 23 october 2017 no anomalies found related to the problem.To date, no similar events have been reported on items of the same lot.Preliminary investigation performed by r&d product manager on (b)(4) 2018 from the description of the event it seems that there is a problem of coupling in the threaded area of the cages.A check of the route card of the lots (143917 and 1720591) shown that there are no out of specification or acceptance in derogation.The m4 thread of the parts is checked at 100% in the final control step.A deeper analysis can be performed during the visual inspection.Visual inspection performed by r&d product manager on (b)(4) 2018 from the visual inspection of the two cages (ref(b)(4) lot.1720591 and ref.(b)(4) lot.143917), it's possible to observe a deformation at the beginning of the m4 thread.This deformation is more visible on the cage 03.27.015.A test with an m4 go/nogo gauge shows a high friction of the go gauge and a visible malpositioning of the gauge.All the cages are tested 100% during the final control so the damaging of the thread occurred during the usage.Taking into consideration all these facts, the root cause could be identified into a cross-threading with the related inner shaft.All the pictures submitted in the complaint for was taken into consideration during this analysis.
Event or Problem Description
The surgeon was not able to insert the mectalif posterior cages into the inner shaft completely.The surgery was finished with the backup implant.Due to this event, the surgery was prolonged for about 10 minutes.The inserting friction force of both cages is higher than that of other cages.

• Brand Name: MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI
• Common Device Name: POSTERIOR INTERBODY FUSION DEVICE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7973283
• Report Number: 3005180920-2018-00797
• Device Sequence Number: 1434891
• Product Code: MAX
• UDI-Device Identifier: 07630030831430
• UDI-Public: 07630030831430
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

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: 10/10/2022
• Device Catalogue Number: 03.27.001
• Device Lot Number: 1720591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/17/2018
• 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