MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X36X9 L5°

Catalog Number	03.26.017
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 13 november 2017.Lot 153189: (b)(4) items manufactured and released on 12 august 2016.Expiration date: 2021-07-21.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.On 15 november 2017 the technical director visually inspected the involved packaging and provided the following comments: the two blisters are not deformed.The inner blister was pulled out successfully from the outer one by using the dedicated tyvek flap: no additional damage to this flap was generated during this attempt (the flap was damaged during surgery).The cause of the blockage must be considered as due to visible micro-sealings, which could have been probably generated during the sealing of the outer tyvek.Considering that: - it was possible to pull out the inner blister from the outer one without damaging the flap further, - the inner blister is undamaged and the sterility is preserved, - no similar case has ever been reported up to date, - the sealing-time for these blisters is already being reduced, we do not foresee a reoccurrence of the same issue and, even in case it would happen again, no patient harm is likely to be caused by this.No actions will be taken.
Event or Problem Description
It was not possible to pull out the inner plastic blister from outer plastic one.The nurse replaced with new box.It looks there is no sign of melting.Inner plastic blister seems not to deformed.

• Brand Name: MECTALIF OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X36X9 L5°
• Common Device Name: INTERBODY FUSION DEVICE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7040117
• Report Number: 3005180920-2017-00682
• Device Sequence Number: 1079656
• Product Code: MAX
• UDI-Device Identifier: 07630030830372
• UDI-Public: 07630030830372
• 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): 11/17/2017

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: 07/21/2021
• Device Catalogue Number: 03.26.017
• Device Lot Number: 153189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 11/17/2017
• 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
• Patient Age: 80 YR