MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW 03.50.403 ROD TI 5.5X480; SPINE PEDICLE SCREW

Model Number	03.50.403
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in for a post-op appointment and x-rays revealed that the rod was broken.The surgeon had to remove the rod and 3 screws 2 years and 1 month after primary.The surgery was completed successfully.The patient was not in any pain once the rod broke.The patient was working out 2-3 times a day.
Additional Manufacturer Narrative
Batch review performed on 14 october 2021: lot 1821287: (b)(4) items manufactured and released on 01-feb-2019.Expiration date: 2024-01-14.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.Clinical evaluation performed by medical affairs director: 2 years after deformity reduction surgery in an adolescent patient, one of the rods, in a region not supported by pedicle screws, broke.According to report, the patient was doing regular workout exercises, and this may have subjected the implants to excessive stress, particularly in the unsupported area, that required additional screws and a new rod.Direct analysis to verify that no defect was present in the rod would have been advisable, but according to report the rod is not available.A reasonable explanation for the fracture of a defect-free rod is available as detailed above.Patient match planning review: our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.

• Brand Name: PEDICLE SCREW 03.50.403 ROD TI 5.5X480
• Common Device Name: SPINE PEDICLE 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: 12786545
• Report Number: 3005180920-2021-00866
• Device Sequence Number: 12035751
• Product Code: KWP
• UDI-Device Identifier: 07630030835360
• UDI-Public: 07630030835360
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2021
• Device Model Number: 03.50.403
• Device Catalogue Number: 03.50.403
• Device Lot Number: 1821287
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2019
• 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
• Patient Age: 18 YR
• Patient Sex: Male