MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X45MM

Catalog Number	03.52.324
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 september 2018; lot 1621163: (b)(4) items manufactured and released on 09 february 2017 expiration date: 2022-01-15; 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.Other device involved: pedicle screw enh.Poly-axial pedicle screw - cannulated 6x50mm reference 03.52.325; (k141988); lot 1621164:(b)(4) items manufactured and released on 02 february 2017.Expiration date: 2022-01-01.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.Clinical evaluation performed by medical affairs (b)(4) on 21 september 2018; few months after one-level lumbar fusion with pedicle screws, the two screws on l5 sheared off.No information were given as to patient weight, activity, no traumatic event was reported.The cause for this incident cannot be determined by clinical analysis.
Event or Problem Description
The surgeon detected that 2 screws broke inside the patient and he plans to revise the components on (b)(6) 2018.
Additional Manufacturer Narrative
Visual inspection performed the 30th of october 2018 by r&d product manager.Pictures received with the complaint notification were also considered.Fracture of two pedicle screws.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 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 a number of non-device-related causes.

• Brand Name: PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X45MM
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7897536
• Report Number: 3005180920-2018-00711
• Device Sequence Number: 11189234
• Product Code: NKB
• UDI-Device Identifier: 07630030857591
• UDI-Public: 07630030857591
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K141988
• 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): 10/31/2018

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: 01/15/2022
• Device Catalogue Number: 03.52.324
• Device Lot Number: 1621163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 10/31/2018
• 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