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

Catalog Number 03.50.030

Device Problem Material Fragmentation (1261)

Patient Problem Pain (1994)

Event Date 09/11/2019

Event Type  Injury  

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 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.

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 Description

Device returned and analysed by medacta r&d.

• Brand Name: PEDICLE SCREW 7X40
• Type of Device: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9195801
• MDR Text Key: 162873570
• Report Number: 3005180920-2019-00866
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 07630030834288
• UDI-Public: 07630030834288
• Combination Product (y/n): N
• PMA/PMN Number: K121115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR