MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW 7X40

Catalog Number	03.50.030
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2019; lot 155082: (b)(4) items manufactured and released on (b)(6) 2015.Expiration date: 2020-09-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.Two equal device were reported in this complaint.
Event or Problem Description
The patient complained about pain during a control visit.Two pedicle screws were found to be broken at s1 level.Revision surgery was performed almost 2 years and a half after primary.The screws' threaded parts were left in the patient.The surgeon implanted a competitor system, the new screws in s1 were implanted with a parallel trajectory.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection performed by medacta spine r&d project manager: the two pedicle screw ref.03.50.030, lot 155082, are broken approximately 10mm below the pedicle screw head.All the other explanted implant are without any damaging.The root cause of the event is unknown, probably is due to a huge load on the lower pedicle screw implanted in s1.Despite of the breakage as reported in the tf: vi-ps-01 the implant, in worst case configuration, can accomplish the requirements of the standard and it's comparable or better refer to the implants already on the market.
Event or Problem Description
Device returned and analysed by medacta r&d.

• Brand Name: PEDICLE SCREW 7X40
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9195801
• Report Number: 3005180920-2019-00866
• Device Sequence Number: 19480292
• Product Code: KWP
• UDI-Device Identifier: 07630030834288
• UDI-Public: 07630030834288
• 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: 2017
• 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): 11/12/2019

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: 09/05/2020
• Device Catalogue Number: 03.50.030
• Device Lot Number: 155082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/12/2019
• 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: 57 YR