MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 ENHANCED; SPINE ANTERIOR STAND-ALONE SCREW

Catalog Number	03.30.132
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: approximately 1 year after alif lumbar stabilization, one of the screws sheared off just below the head.This kind of occurrence may intervene when the expected fusion, in this case l5-s1, did not occur.We could not find reports of clinical problems: if the fusion intervened afterwards it is possible that no intervention is required.The report does not specify how, ong after primary surgery the screw was found to be broken.With the information at hand, we cannot draw any conclusion for the scope of the clinical investigation.Batch review performed on 18 june 2019: lot 1720418: (b)(4) items manufactured and released on 22 november 2017 expiration date: 2022-11-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 1 similar reported event.
Event or Problem Description
Screw breakage after about 1 year from primary surgery.No revision surgery has been performed for the moment.

• Brand Name: MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 ENHANCED
• Common Device Name: SPINE ANTERIOR STAND-ALONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8764307
• Report Number: 3005180920-2019-00541
• Device Sequence Number: 14084272
• Product Code: OVD
• UDI-Device Identifier: 07630030875427
• UDI-Public: 07630030875427
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K160605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/05/2019

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: 11/02/2022
• Device Catalogue Number: 03.30.132
• Device Lot Number: 1720418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 07/05/2019
• 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