MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW PEDICLE SCREW 6X40

Catalog Number	03.50.017
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 september 2018; lot 1721184: (b)(4) items manufactured and released on 08 february 2018.Expiration date: 2023-01-21; no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without similar reported event other devics involved: reference 03.50.017 (k121115) pedicle screw 6x40; lot 1721174: (b)(4) items manufactured and released on 08 february 2018 expiration date: 2022-11-16; 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.Reference 03.50.017 (k121115) pedicle screw 6x40; lot 147482: (b)(4) items manufactured and released on 21 november 2014.Expiration date: 2019-10-22; 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.Mectalif posterior (ti peek) posterior interbody fusion device peek/ti 11x22x9 l5° reference 03.27.007 (k133192); lot 1720715: (b)(4) items manufactured and released on 11 may 2018.Expiration date: 2023-04-19; 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.Clinical evaluation performed by medical affairs (b)(4) on 21 september 2018; lumbar l4-l5 fusion with plif cage and pedicle screws.According to report, one of the 4 set screws loosened after few days.Also the cage was found to have migrated.We cannot imagine a clinical cause for the loosening of the screw after such a short time.One possibility could be technical error but we have no evidence in either sense.From the clinical point of view, the cause cannot be determined.Visual inspection performed on september the 19th, 2018 by r&d product manager the implant, ref.03.27.007, lot 1720715 analized, is according to the specification for which concern dimensions and material.There are small scratches on the coating surface probably due to the removal operation, see pictures enclosed.Quality control department inspected the returned torque limiter, no anomalies found.Piece is conforming to specification.
Event or Problem Description
The patient alleged pain and abnormal feeling a week after primary surgery (plif due to l4 spondylolisthesis).The surgeon confirmed that the cage migrated.Revision surgery performed two weeks after the primary and the surgeon confirmed the set screw at l5 left side loosen.The surgeon replaced the cage and all set screws.

• Brand Name: PEDICLE SCREW PEDICLE SCREW 6X40
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7897546
• Report Number: 3005180920-2018-00717
• Device Sequence Number: 16532110
• Product Code: KWP
• UDI-Device Identifier: 07630030834202
• UDI-Public: 07630030834202
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2018

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: 01/21/2023
• Device Catalogue Number: 03.50.017
• Device Lot Number: 1721184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 09/21/2018
• 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
• Patient Age: 59 YR
• Patient Weight: 49