MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR TI-PEEK CAGE; ANTERIOR CAGE

Catalog Number	03.31.008
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 02 january 2018 on implant and instruments involved: implants: mectalif anterior stand-alone cage code 03.31.008 lot.142311: (b)(4) items manufactured and released on 12 december 2016.Expiration date: 2021-11-23.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Mectalif anterior plate flush h.14 mm code 03.30.202 lot.148305 (k124034): (b)(4) items manufactured and released on 12 june 2015.Expiration date: 2020-05-05.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Instrument: mectalif anterior trial flush - 31x24 - h.14 code 03.30.10.1272 lot.1654845: (b)(4) items manufactured and released on 07 march 2017.No anomalies found related to the issue.
Event or Problem Description
The surgeon performed a trial using the alif trial flush - 31x24 - h.14 - l.10°, it fitted correctly; he then implanted the plate h.14 and the cage 24x31x14 l.10° but the implant was loose in the intervertebral disc space.Therefore, he performed a second trial using a bigger size, alif trial flush - 27x35x16 l.15°, implanting then the cage 27x35x16 l.15° that fitted correctly.It was supposed that the first trial flush had a different height compared with the implant.
Additional Manufacturer Narrative
On 09 january 2018 r&d department performed the following investigation on the returned items: the cage 03.31.008 lot 142311, the plate 03.30.202 lot 148305 and the trial (b)(4) received from the complaints was measured and they are according the specification, specified by the design surgeons.The e alif device flush h.14 over imposed on the trial have the same shape considering also the teeth dimension.The route cause of the different feeling is the section can give to the surgeon the feeling of a different friction.The difference for each side is 0.4mm for a small area.
Event or Problem Description
The surgeon performed a trial using the alif trial flush - 31x24 - h.14 - l.10°, it fitted correctly; he then implanted the plate h.14 and the cage 24x31x14 l.10° but the implant was loose in the intervertebral disc space.Therefore, he performed a second trial using a bigger size, alif trial flush - 27x35x16 l.15°, implanting then the cage 27x35x16 l.15° that fitted correctly.It was supposed that the first trial flush had a different height compared with the implant.

• Brand Name: MECTALIF ANTERIOR TI-PEEK CAGE
• Common Device Name: ANTERIOR CAGE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7163361
• Report Number: 3005180920-2017-00815
• Device Sequence Number: 11131880
• Product Code: OVD
• UDI-Device Identifier: 07630030833816
• UDI-Public: 07630030833816
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160605
• 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,Followup
• Report Date (Section B): 02/02/2018

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: 11/23/2021
• Device Catalogue Number: 03.31.008
• Device Lot Number: 142311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 02/02/2018
• 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