MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED (DOUBLE PACKAGING); SPINE STAND-ALONE SCREW

Catalog Number	03.30.133
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 13 august 2019 lot 1620158: (b)(4) items manufactured and released on 27-jul-2016.Expiration date: 2021-07-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 2 other similar reported event.Screw breakage occurred 3 months after implantation.In spinal fusion, surgery instrumentation is used as a temporary stabilizer until osseous fusion is complete.Without osseous fusion implants are prone to eventual failure under physiological mechanical stress.In this case the reason of fusion failure is not known: no information concerning patient general health status and comorbidities that could have prevented bone formation is available.Our opinion, based on the available information, is that failed fusion is the most likely cause for this fracture.Only 1 screw is broken but it is unknown which one it is.So here below details of other ref.And lot number of screw used.Batch review performed on 13 august 2019: mectalif anterior 03.30.133 mectalif anterior stand-alone screw diam.5x35 enhanced (double packaging) lot.1820443 (k160605): (b)(4) items manufactured and released on 28-jun-2018.Expiration date: 2023-05-14.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 for a post-op x-ray 2 months and 10 days after primary and it was observed that an alif screw had fractured.The reason for the screw fracture is unknown.The surgeon does not plan on revising the patient at this time, but will monitor the patient.

• Brand Name: MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED (DOUBLE PACKAGING)
• Common Device Name: SPINE STAND-ALONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8955164
• Report Number: 3005180920-2019-00745
• Device Sequence Number: 2041644
• Product Code: OVD
• UDI-Device Identifier: 07630030875434
• UDI-Public: 07630030875434
• 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): 09/03/2019

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: 07/17/2021
• Device Catalogue Number: 03.30.133
• Device Lot Number: 1620158
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 09/03/2019
• 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