MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW MUST LT 15MM SHORT - PEDICLE SCREW Ø4.5X30 CANN

Catalog Number	03.57.002
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 31-oct-2023.Lot 2227012: (b)(4) items manufactured and released on 08-mar-2023.Expiration date: 2028-02-14.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.2 items in this complaint.Pedicle screw 03.57.003 must lt 15mm short - pedicle screw ø4.5x35 cann (k203482) lot: 2224911: (b)(4) items manufactured and released on 13-jul-2022.Expiration date: 2027-06-26.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.3 items in this complaint.Pedicle screw 03.57.003 must lt 15mm short - pedicle screw ø4.5x35 cann (k203482) lot 2222978: (b)(4) items manufactured and released on 23-jun-2022.Expiration date: 2027-05-31.No anomalies found related to the problem.To date, no items of the same lot have been sold.
Event or Problem Description
All pedicle screws loosened during final fixation of set screws (t4-t7 fixation).All screws were replaced with 30 minutes of delay, 4 hours of surgery.The patient bone was weak.
Additional Manufacturer Narrative
Devices received on 16 nobember 2023 and analyzed by medacta spine r&d project manager on 21 november 2023: no visible defect can be found.The most probable root cause for the screw loosening is the weakness of the patient's bone.

• Brand Name: PEDICLE SCREW MUST LT 15MM SHORT - PEDICLE SCREW Ø4.5X30 CANN
• Common Device Name: PEDICLE SCREW
• 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: 18091488
• Report Number: 3005180920-2023-00883
• Device Sequence Number: 6680825
• Product Code: NKB
• UDI-Device Identifier: 07630971278226
• UDI-Public: 07630971278226
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.57.002
• Device Lot Number: 2227012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2023
• 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: 82 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian