MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYSPINE MC DRILL BASED GUIDE L05; DRILL GUIDE

Catalog Number	7.0725
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27-nov-2019.Lot 02291s: (b)(4) items manufactured and released on 31-oct-2019.Expiration date: 2020-04-21.No anomalies found related to the problem.Clinical evaluation: in spinal lumbar fusion surgery aided by patient specific guides, one of the screws is found to be in a position judged incorrect by the surgeon.No device-related problem is expected to have caused this situation.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.Other devices involved in the event.Pedicle screw 03.52.323 enh.Poly-axial pedicle screw - cannulated 6x40mm lot.1921244 (k141988).Batch review performed on 27-nov-2019.Lot 1921244: (b)(4) items manufactured and released on 12-aug-2019.Expiration date: 15.07.2024.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Pedicle screw 03.52.323 enh.Poly-axial pedicle screw - cannulated 6x40mm lot.1921988 (k141988).Batch review performed on 27-nov-2019.Lot 1921988: (b)(4) items manufactured and released on 30-aug-2019.Expiration date: 18.08.2024.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Revision surgery performed due to back pain.The trajectory of the pedicle screw in l5 right was not correct and the tip protruded out of the pedicle, it was repositioned the same screw.Case code: (b)(6).

• Brand Name: MYSPINE MC DRILL BASED GUIDE L05
• Common Device Name: DRILL GUIDE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9443539
• Report Number: 3005180920-2019-01034
• Device Sequence Number: 14260598
• Product Code: PQC
• UDI-Device Identifier: 07630040717557
• UDI-Public: 07630040717557
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K173472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2019

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: 04/21/2020
• Device Catalogue Number: 7.0725
• Device Lot Number: 02291S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR