MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SPINE BENT ROD TI 5.5X55MM; SPINE ROD

Model Number	03.50.454
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department: at about 8 months after primary spinal stabilization surgery (l3-l4) using a posterior instrumetantion (screws and rods) and an interbody fusion device, the left rod (ti 5.5x55mm) broke.Patient falls or other events that could explain the breakage are not reported.A revision surgery was performed to change the broken rod: pedicle screws appeared stable and were not revised.No sign of infection were detected.The aim of the surgery was the osseous fusion that is usually reached in 6-8 months.In this case, the absence of an effective osseous fusion may have subjected the implant to overload leading to breakage of the rod.We have no reason to suspect a defective or malfunctioning device.
Event or Problem Description
At about 8 months after primary (spondylodese), revision surgery performed due to left bent rod ti 5.5x55mm breakage.The surgeon revised successfully the broken rod.Pedicle screws remained stable.No infection.
Event or Problem Description
At about 8 months after primary (spondylodese), revision surgery performed due to left bent rod ti 5.5x55mm breakage.The surgeon revised successfully left broken rod and right rod.Pedicle screws remained stable.No infection.The surgeon also proceeded to extend the patients construct.
Additional Manufacturer Narrative
Batch review performed on 24 july 2023 lot 2124985: (b)(4) items manufactured and released on 04-nov-2021.Expiration date: 2026-10-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Visual inspection performed by r&d project manager ref.03.50.454 bent rod ti 5.5x55mm lot.2124985 the rod broke in a way compatible with material fatigue.No traumatic event that may have caused weakening or premature failure of the implant has been reported.A potential root cause may be the lack of bone fusion, that stressed the implant over the intended endurance.

• Brand Name: SPINE BENT ROD TI 5.5X55MM
• Common Device Name: SPINE ROD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17215113
• Report Number: 3005180920-2023-00448
• Device Sequence Number: 15010781
• Product Code: KWP
• UDI-Device Identifier: 07630030835537
• UDI-Public: 07630030835537
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 07/28/2023

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 Model Number: 03.50.454
• Device Catalogue Number: 03.50.454
• Device Lot Number: 2124985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2021
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White