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

Model Number	03.52.324
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 july 2020.Lot 1921976: (b)(4) items manufactured and released on 15-nov-2019.Expiration date: 2024-11-03.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 devices were reported in this case.
Event or Problem Description
Spinal fixtaion was performed at l4-l5 by pps initially.When the surgeon tried to perform the reduction at the both side of l4, the both side of pedicle screws were pulled out from the patient bone.The surgeon removed the pedicle screws at the both side of l4, and inserted the pedicle screws which were removed from the l4 at the both side of l3.The surgeon inserted the more larger size pedicle screws at l4 and replaced 2 rods.Finally, l3-l5 was fixed.Due to this event the surgery was prolonged about 30 minutes.Total surgery time was about 3 hours.The surgeon expressed an opinion that the selection of the pedicle screw size was correct.The fixation strength of 6mm screw seemed to be less effective.

• 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, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10349976
• Report Number: 3005180920-2020-00476
• Device Sequence Number: 3064961
• Product Code: NKB
• UDI-Device Identifier: 07630030857591
• UDI-Public: 07630030857591
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2020

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: No Information
• Device Expiration Date: 11/03/2024
• Device Model Number: 03.52.324
• Device Catalogue Number: 03.52.324
• Device Lot Number: 1921976
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 07/31/2020
• 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: Other