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

Catalog Number	03.50.030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 october 2018.Lot 153392: (b)(4) items manufactured and released on 25 june 2015.Expiration date: 2020-05-20.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 director on oct 31, 2018: one year after a two-level posterior lumbar stabilization in a heavy female patient, one of the screws in s1 was found broken and replaced.From the "xrays" images we could not detect any particular fault in the placement of the screws.The broken screw is "probbaly" a sign that fusion did not occur after 1 year.This is a possible adverse event following spinal stabilization; the screws cannot be dimensioned to hold indefinitely and if after 1 year fusion has not happened, it is possible to have fatigue fracture.This does not automatically imply a defect of the implanted device.
Event or Problem Description
Revision surgery performed after about 1 year from primary due to lumbar pain: a screw located in s1, left side, was found broken.
Additional Manufacturer Narrative
Visual inspection performed on november the 23rd, 2018 by r&d product manager: the visual inspection performed on pedicle screw 03.50.030, lot 153392, shown that the part is broken in the screw area but it's not affected by other issues.The screw breakage may be the result of fatigue loading, influenced by the particular anatomical conditions and dynamics.The device history record does not indicate any potentially related manufacturing issue and the device feedback history confirms there to be no recurring issue with the device system regarding this type of event.In conclusion, no manufacturing or design related root cause can be identified, and no systemic deficiency of the system is indicated by this individual occurrence.During the visual inspection, it has been taken in consideration also the pictures and the x-ray provided in the complaint.

• Brand Name: PEDICLE SCREW 7X40
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8023976
• Report Number: 3005180920-2018-00843
• Device Sequence Number: 16583297
• Product Code: KWP
• UDI-Device Identifier: 07630030834288
• UDI-Public: 07630030834288
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K121115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/20/2020
• Device Catalogue Number: 03.50.030
• Device Lot Number: 153392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 12/19/2018
• 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: 39 YR
• Patient Weight: 81