MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAMETER 4X16MM; CERVICAL SCREW

Catalog Number	03.70.277
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on 24 november 2017.Six months after primary surgery, a screw of a cervical plate broke in the vertebral body.The cause for fracture is probably delayed fusion; all these implants are meant to carry load only temporarily.As the implant has not been retrieved, we could not analyze it in order to verify if a manufacturing defect is present.The possibility of fusion for the patient is probably hindered but not definitely compromised; at 9 months, it seems improved but clinical analysis is not available.Batch review performed on 01 december 2017: lot 141344: 104 items manufactured and released on 22-oct-2014.Expiration date: 30- sept- 2019.No anomalies found related to the problem.To date, 32 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Medacta international was informed on (b)(6) 2017 about a screw breakage occurred few months before.The event was noticed during a post-operative control.To date, we do not know if the revision surgery has been performed or not.

• Brand Name: CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAMETER 4X16MM
• Common Device Name: CERVICAL SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7078895
• Report Number: 3005180920-2017-00722
• Device Sequence Number: 16593868
• Product Code: KWQ
• UDI-Device Identifier: 07630030841347
• UDI-Public: 07630030841347
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K140361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2017

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: 09/30/2019
• Device Catalogue Number: 03.70.277
• Device Lot Number: 141344
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2017
• Initial Report FDA Received Date: 12/04/2017
• 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: Required Intervention
• Patient Age: 55 YR