MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X25 ENHANCED; SPINE ANTERIOR STAND-ALONE SCREW

Catalog Number	03.30.131
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 april 2019: lot 1820615: (b)(4) items manufactured and released on 20-jul-2018.Expiration date: 2023-07-08.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.As the screw is still in situ, it is impossible to define which lot is the involved one, so the batch record of the second possible lot has been performed as well: mectalif anterior 03.30.132 mectalif anterior stand-alone screwdiam.5x30 enhanced (double packaging) lot 1820442 (k160605): (b)(4) items manufactured and released on 20-jul-2018.Expiration date: 2023-07-09.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.Clinical evaluation performed by medical affairs director.This patient complains for pain shortly after an l5s1 fusion that gave very early a broken screw in s1.A disc replacement device is visible at l4l5 and the distal lumbar lordosis appears to be very pronounced.We do not know if the cause of pain is directly the broken screw.We cannot determine with certainty the cause for screw fracture either, but the combination between vertebral angles and adjacent disc replacement device seems to be a mechanically challenging situation.The cause for this fracture cannot be ascertained through clinical investigation only.
Event or Problem Description
The patient came in complaining of pain which was caused by a broken mectalif anterior screw in the s1 vertebrae and the cause of the broken screw is unknown.The surgeon has not scheduled a revision surgery at this time.

• Brand Name: MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X25 ENHANCED
• Common Device Name: SPINE ANTERIOR STAND-ALONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8522860
• Report Number: 3005180920-2019-00275
• Device Sequence Number: 14152841
• Product Code: OVD
• UDI-Device Identifier: 07630030875410
• UDI-Public: 07630030875410
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2019

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: 07/08/2023
• Device Catalogue Number: 03.30.131
• Device Lot Number: 1820615
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/17/2019
• 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