MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM

Model Number	03.52.323
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19-may-2020: 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.Patient match planning review performed by mysolution department.Our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.Additional implant involved: pedicle screw 03.52.322 enh.Poly-axial pedicle screw - cannulated 6x35mm (k141988) lot.1923102.Batch review performed on 19-may-2020: lot 1923102: (b)(4) items manufactured and released on 21-oct-2019.Expiration date: 02.10.2024.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
The patient had a myspine mc surgery in (b)(6) 2020 and was revised one day after due to pain, a cage has been removed.Initially, a decompression was on one side, during the revision surgery it was done also on the second side.On (b)(6) of 2020 the patient underwent revision surgery again due to pedicle screws loosening.The patient has osteoporotic bone.

• Brand Name: PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10081873
• Report Number: 3005180920-2020-00288
• Device Sequence Number: 14162104
• Product Code: NKB
• UDI-Device Identifier: 07630030857584
• UDI-Public: 07630030857584
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2020

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: 08/18/2024
• Device Model Number: 03.52.323
• Device Catalogue Number: 03.52.323
• Device Lot Number: 1921988
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 05/22/2020
• 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: 79 YR