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

Catalog Number	03.52.730
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31 october 2018.Lot 1720581: (b)(4) items manufactured and released on 05 january 2018.Expiration date: 2022-12-10.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.Visual inspection performed the 30th of october 2018 by r&d product manager: only the implant (pedicle screw) was returned.The implant looks intact without signs of defect.The event seem related to "uncomfort" with the design/ergonomics of the instrument; however, no failure/damage/"breackage" of the same can be assessed.Alternative designs of compression devices are available and more under development.Other device involved: pedicle screw compression pliers, reference 03.51.10.0041, lot.Unknown.
Event or Problem Description
The pedicle screw loosened when compressed with the compression pliers.The pedicle screw was replaced and a backup instrument used.No vertebra damages.The surgery was completed successfully and without delay.

• Brand Name: PEDICLE SCREW REDUCTION CANNULATED PEDICLE SCREW 7X40
• Common Device Name: REDUCTION CANNULATED PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8023995
• Report Number: 3005180920-2018-00851
• Device Sequence Number: 1380532
• Product Code: NKB
• UDI-Device Identifier: 07630030847219
• UDI-Public: 07630030847219
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153664
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• 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: 12/10/2022
• Device Catalogue Number: 03.52.730
• Device Lot Number: 1720581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2018
• Initial 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