MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CERVICAL PLATE VARIABLE SELF-TAPPING SCREW DIAM. 4X14MM (2X)

Catalog Number	03.70.055
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Three pieces of the lot 141356 and a piece of the lot 141188 reference 03.70.240 (k140361); cervical plate l2x40mm were removed due to left arm and neck pain 3 years and 3 months after primary.The patient has pseudoarthrosis.A piece of the lot 141356 was found broken by the surgeon.Batch review performed on 05 june 2018; lot 141356: (b)(4) items manufactured and released on 22 october 2014 expiration date: 2019-08-31 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.
Event or Problem Description
The patient came in complaining of left arm and neck pain 3 years and 3 months after primary.The patient has pseudoarthrosis.The surgeon removed medacta screws and 1 plate.One screw could have not been removed as the head was found broken during revision.The surgeon was able to recover the head of the screw.The surgery was completed successfully.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on 11 june 2018: revision surgery occurred 3 years after primary procedure due to pseudarthrosis.Incomplete fusion is a possible adverse events and may be due to different factors either mechanical or patient related.On the basis of the information provided it is not possible to determine when the screw breakage occurred and its relation with pseudoarthrosis.

• Brand Name: CERVICAL PLATE VARIABLE SELF-TAPPING SCREW DIAM. 4X14MM (2X)
• Common Device Name: VARIABLE SELF-TAPPING SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7582505
• Report Number: 3005180920-2018-00409
• Device Sequence Number: 1758964
• Product Code: KWQ
• UDI-Device Identifier: 07630030840333
• UDI-Public: 07630030840333
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 03.70.055
• Device Lot Number: 141356
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/10/2018
• Supplement Date Received by Manufacturer: 06/10/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 07/10/2018
• 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: Required Intervention
• Patient Age: 76 YR