MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW MONOAXIAL SCREW 5X40MM

Catalog Number	03.50.233
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	08/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the reporter was not sure about which was the correct lot of the explanted screw, we performed a batch review for each lot of the screw that were implanted during primary surgery: batch review performed on 09 sept 2019- lot 152470: (b)(4) items manufactured and released on 23-sep-2015.Expiration date: 2020-08-17.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.Pedicle screw 03.50.222 monoaxial screw 4.5x35mm (k132878), lot.152464.Batch review performed on 09 sep 2019- lot 152464: (b)(4) items manufactured and released on 11-dec-2015.Expiration date: 2020-11-10.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.Pedicle screw 03.50.253 monoaxial screw 7x40mm (k132878), lot.152481.Batch review performed on 9 sep 2019- lot 152481: (b)(4) items manufactured and released on 17-nov-2015.Expiration date: 2020-10-18.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.Pedicle screw 03.50.255 monoaxial screw 7x50mm (k132878), lot.152483.Batch review performed on 09 sep 2019- lot 152483: (b)(4) items manufactured and released on 06-nov-2015.Expiration date: 2020-10-14.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.Pedicle screw 03.50.232 monoaxial screw 5x35mm (k132878), lot.152469.Batch review performed on 09 sep 2019- lot 152469: (b)(4) items manufactured and released on 23-sep-2015.Expiration date: 2020-08-17.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.Pedicle screw 03.50.254 monoaxial screw 7x45mm (k132878), lot.152482.Batch review performed on 09 sep 2019- lot 152482: (b)(4) items manufactured and released on 23-nov-2015.Expiration date: 2020-10-13.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 pedicle screw 03.50.243 monoaxial screw 6x40mm (k132878), lot.152475.Batch review performed on 09 sep 2019- lot 152475: (b)(4) items manufactured and released on 16-nov-2015.Expiration date: 2020-10-06.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.
Event or Problem Description
The patient came in, 5 days after primary surgery, complaining of bilateral knee numbness.The surgeon revised one broken pedicle screw.The surgery was completed successfully.

• Brand Name: PEDICLE SCREW MONOAXIAL SCREW 5X40MM
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8979017
• Report Number: 3005180920-2019-00763
• Device Sequence Number: 16201941
• Product Code: NKB
• UDI-Device Identifier: 07630030834981
• UDI-Public: 07630030834981
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2019

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: 08/17/2020
• Device Catalogue Number: 03.50.233
• Device Lot Number: 152470
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/10/2019
• 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