MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYSPINE; SPINE SURGICAL GUIDES

Model Number	7.0726
Medical Device Problem Codes	Osseointegration Problem (3003); Positioning Problem (3009)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Spinal fixation was performed at l4-s1 with myspine mc guides.The surgeon felt that the guide did not fit the vertebral body at l4-s1.The surgeon used the guides anyways, except for the right side of l5, where he inserted the pedicle screw (5.5 x 30mm) by freehand.After decompression, the pedicle screw loosen, so the right side of l5 was skipped.The surgery was completed with 30 min delay (tot time 5 hours).The surgeon suspects that the guides are for the wrong patient.
Additional Manufacturer Narrative
Batch review performed on 04 sept 2024 lot 14461s: (b)(4) items manufactured and released on 19-aug-2024.Expiration date: 2025-02-01.No anomalies found related to the problem.Planning review and analysis performed by my solution department: our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.We reproduced the guides and the fitting of all the levels are conform.The guides are completely stable.For all cases it is not possible to develop a guide on the wrong patient as during image quality control we also have that check to do.If the case code has any discrepancies from the data that is filled by the radiology centre during ct acquisition, we always ask for confirmation from sales and until we receive it the case will remain blocked.Additional implant involved: batch review performed on 04 sept 2024 on pedicle screw 03.58.232 must mc screw ø5.5x30 cannulated (k210427) lot.2325059 lot 2325059: (b)(4) items manufactured and released on 13-oct-2023.Expiration date: 2028-09-18.No anomalies found related to the problem.To date, xx items of the same lot have been sold with no similar reported event during the period of review.
Additional Manufacturer Narrative
Additional implant involved: batch review performed on 04 sept 2024 on pedicle screw 03.58.232 must mc screw ø5.5x30 cannulated (k210427) lot.2325059 lot 2325059: 50 items manufactured and released on 13-oct-2023.Expiration date: 2028-09-18.No anomalies found related to the problem.To date, only this item of this lot has been sold.Visual inspection performed by r&d departement: the implant (pedicle screw must mc screw ø5.5x30 cannulated) is conform.The external diameter and the thread are conform.The root cause could not be associated to the implant.It can be confirmed that the vertebral models received correspond to the patient's anatomy for which ct scan has been received.No issues detected.Root-cause description: the implant and the vertebral models are conform.The device history record review does not indicate any potentially related manufacturing issue and the mysolution planning review did not find any anomaly in the process.The issue may relate to unique circumstances present only at the time of application, but no confirmation can be made at this time.Correction: - d1 brand name corrected - d4 model number inserted in the correct position - batch review of lot.2325059 corrected.Device evaluation: - devices returned on 10.01.2024 - visual inspection performed.

• Brand Name: MYSPINE
• Common Device Name: SPINE SURGICAL GUIDES
• 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: 20320898
• Report Number: 3005180920-2024-00768
• Device Sequence Number: 8005344
• Product Code: PQC
• UDI-Device Identifier: 07630040717571
• UDI-Public: 07630040717571
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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 Expiration Date: 02/01/2025
• Device Model Number: 7.0726
• Device Catalogue Number: 7.0726
• Device Lot Number: 14461S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• 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: 83 YR
• Patient Sex: Female
• Patient Weight: 43 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian