MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X18MM (2X); SPINE SELF-TAPPING SCREW

Model Number	03.70.279
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 11 sept 2021: lot 1921601: (b)(4) items manufactured and released on 22-nov-2019.Expiration date: 2024-oct-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Another devices involved: batch review performed on 11 sept 2021: cervical plate 03.70.277 fixed self-tapping screw diam.4x16mm (2x) (k140361) lot 1920104: (b)(4) items manufactured and released on 05-nov-2019.Expiration date: 2024-oct-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Cervical plate 03.70.264 fixed self-tapping screw diam.4x16mm (1x) (k140361) lot 141341a: (b)(4) items manufactured and released on 30-sept-2019.Expiration date: 2024-aug-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Cervical plate 03.70.277 fixed self-tapping screw diam.4x16mm (2x) (k140361) lot 1921587: (b)(4) items manufactured and released on 29-oct-2019.Expiration date: 2024-oct-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
3 months after the primary surgery the c7 screw on the right side is broken, and additionally, it is suspected that the screw on the left side is loosed.The patient was in an asymptomatic condition, therefore no revision surgery was planned initially.One month after, other screws had broken (in c6 level), and the revision surgery was planned.It is unknown how many screws are broken at this moment and whether broken screws will be explanted.
Event or Problem Description
At 3 months after the primary surgery, the c7 screw on the right side is broken, and additionally, it is suspected that the screw on the left side is loose.The patient was in an asymptomatic condition, therefore no revision surgery was planned initially.One month after, other screws had broken (in c6 level).On (b)(6) 2021, 4 months after the primary surgery, additional surgery was performed.In total, four screws were found broken (c6 and c7 levels on both sides).No implants have been revised as the patient was in an asymptomatic condition.To stop additional screw loosening or breaking, a 360° fixation was taken.
Additional Manufacturer Narrative
Clinical evaluaton: in a 4-level cervical stabilization construct, few months after surgery one screw (right at c7) broke, and soon after also both screws implanted at c6 are found broken.Screw breakages are a possible adverse event, described in literature; the event usually takes place when fusion is not achieved.To date, there are no clues that may lead to think of a defective device.Additional surgery was undertaken to give further stability and a 360° approach was chosen.Preliminary investigation performed by spine r&d director as reported in the literature screw breakages in the cervical spine (plates) can occur among others in case of instability, in some of these cases additional fixation e.G, with posterior instrumentation is required to achieve the stability required for fusion.

• Brand Name: CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X18MM (2X)
• Common Device Name: SPINE SELF-TAPPING SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12473832
• Report Number: 3005180920-2021-00754
• Device Sequence Number: 1100837
• Product Code: KWQ
• UDI-Device Identifier: 07630030841361
• UDI-Public: 07630030841361
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/21/2024
• Device Model Number: 03.70.279
• Device Catalogue Number: 03.70.279
• Device Lot Number: 1921601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male