MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW 6X45

Catalog Number	03.50.018
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018: lot 131111: 150 items manufactured and released on 07 march 2013.Expiration date: 2018-01-31.No anomalies found related to the problem.To date, 144 items of the same lot have been already sold without any similar reported event.Visual inspection performed on (b)(6) 2018 by r&d product manager: pictures received with the complaint have been also considered.The breakage occurred below the head of the screw, which is the most stressed point as expected by the risk analysis.There is no sign of material or geometry defect that could have caused the failure.The breakage appears as a typical failure of implant under fatigue loading.This kind of breakage is a common event for pedicle screws in case of delayed fusion, or screw loosening, or spinal construct instability, which might be caused by a number of non-device-related causes.Clinical evaluation performed by medical affairs director on (b)(6) 2018: removal of broken pedicle screw 2 years after surgery.The quality of the single xray supplied does not allow to evaluate fusion level.The xray does not display the date of the image.Pedicle screws often suffer fatigue fractures when fusion did not take place and the device is continuously stressed: this is likely to be the clinical cause for fracture, but the information received does not allow a definite conclusion to be drawn.No particular comments can be made on screw positioning: from the one xray image, no major anomalies are identified.
Event or Problem Description
Revision surgery performed two years after primary due to pain caused probably by a pedicle screw breakage.

• Brand Name: PEDICLE SCREW 6X45
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7233960
• Report Number: 3005180920-2018-00007
• Device Sequence Number: 11131845
• Product Code: KWP
• UDI-Device Identifier: 07630030834219
• UDI-Public: 07630030834219
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K121115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/01/2018

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: 01/31/2018
• Device Catalogue Number: 03.50.018
• Device Lot Number: 131111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 02/01/2018
• 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: 50 YR