MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW BENT ROD TI 5.5X45MM; PEDICLE SCREW ROD

Catalog Number	03.50.452
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 december 2018: lot 1720407: (b)(4) items manufactured and released on 11-october-2017.Expiration date: 2022-10-01.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 component involved: pedicle screw 03.50.017 pedicle screw 6x40 (k121115) lot 1720749: (b)(4) items manufactured and released on 20-oct-2017.Expiration date: 2022-10-04.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.Clinical evaluation performed by medical affairs director: ten months after primary lumbo-sacral stabilization by pedicle screws one of the sacral screws was found broken along with one of the 45mm pre-bent rods.Probably fusion did not take place and in these conditions the fatigue life of the stabilizing devices is limited.From the clinical point of view, a possible cause for the failure is lack of fusion.Technical investigation should be carried out on the explants to exclude possible defects.
Event or Problem Description
First surgery: (b)(6) 2018; stabilization l5-s1 (6x40 screws and 45mm ti prebent rods).After 3 months from first surgery, a tac exam revealed the breakage of the right rod and the left screw in s1.The patient was re-operated on (b)(6): removal of all screws and rod (the distal part of the broken screw remains in the sacrum) and fixation l4-s1 with competitor stabilization system.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: the breakage occurred below the head of the screw, which is the most stressed point as expected by the risk analysis.There is no sign of material or geometry defect that could have caused the failure.The breakage appears as a typical failure of the implant under fatigue loading.This kind of breakage is a common event for pedicle screws in case of delayed fusion, or screw loosening, or spinal construct instability, which might be caused by different non-device-related causes.

• Brand Name: PEDICLE SCREW BENT ROD TI 5.5X45MM
• Common Device Name: PEDICLE SCREW ROD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8141712
• Report Number: 3005180920-2018-00974
• Device Sequence Number: 1746216
• Product Code: KWP
• UDI-Device Identifier: 07630030835513
• UDI-Public: 07630030835513
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K121115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2019

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: 10/01/2022
• Device Catalogue Number: 03.50.452
• Device Lot Number: 1720407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 02/07/2019
• 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: 59 YR
• Patient Weight: 72