MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM

Catalog Number	03.52.322
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 august 2019.Lot 1920237: (b)(4) items manufactured and released on 22-mar-2019.Expiration date: 2024-03-09.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.Additional implant involved pedicle screw 03.52.322 enh.Poly-axial pedicle screw - cannulated 6x35mm (k141988) lot.1822132.Batch review performed on 26 august 2019.Lot 1822132: (b)(4) items manufactured and released on 23-jan-2019.Expiration date: 2024-01-08.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.
Event or Problem Description
The primary surgery performed at l4-l5-s1 on august 1.Revision surgery performed on august 20 due to the pedicle screw loosening at both of l4.The reason of the loosening was unknown.
Additional Manufacturer Narrative
Visual inspection performed by medacta r&d spine project manager: the two pedicle screws inserted in l4 loosened and were substituted with a revision surgery.The two removed screws do not present any scratches and their functionality have been successfully verified in terms of coupling with the screwdriver (both torx and threaded connection), k-wire and reduction towers (e.G.With the 1-step reducer).For these reasons, the root cause that led to the performed revision surgery, cannot be addressed to any mechanical or functional implant defects.

• Brand Name: PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9086487
• Report Number: 3005180920-2019-00773
• Device Sequence Number: 2763306
• Product Code: NKB
• UDI-Device Identifier: 07630030857577
• UDI-Public: 07630030857577
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2024
• Device Catalogue Number: 03.52.322
• Device Lot Number: 1920237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 10/23/2019
• 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