MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW 7X50

Catalog Number	03.50.032
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed on 23 february 2018 by medical affairs director: set screws fracture in a three-level lumbar fusion extending down to s1.From the xrays we are unable to determine which screws are fractured.According to report, the cause for revision was screw loosening.The time when the screws broke was not determined.We are unable to draw conclusions on this case with the elements at hand.Preliminary investigation performed by r and d product manager on 23 february 2018: revision surgery due to pseudo arthrosis after 9 months from the first surgery.Pseudo arthrosis is a typical long term failure of a spinal fixation construct, in case of delayed fusion, screw loosening or spinal construct instability, which might be caused by a number of non-device-related causes.During the intervention the surgeon fount 3 set screws broken.The pictures received don't allow to clearly identify the breakage of the set screws, nor to define whiter the breakage occurred during the surgery (primary or revision) or during the permanence of the implant in the patient.The set screws are made in standard material for this applications.In case of pseudo arthrosis, the spinal construct is subject to abnormal high forces for long term, which might lead to breakage of the most stressed components: screw shaft or spinal rod.Fracture of the set screw is an unlikely event and might be caused to atypical forces/maneuvers applied during the primary surgery, or to a specific event such as a trauma.Batch review performed on 23 february 2018 (b)(4).Pedicle screw 7x40 reference 03.50.030 (k121115) (b)(4).Pedicle screw 7x40 reference 03.50.030 (k121115) (b)(4).Pedicle screw 7x45 reference 03.50.031 (k121115) (b)(4).Pedicle screw 7x45 reference 03.50.031 (k121115) (b)(4).Pedicle screw 7x45 reference 03.50.031 (k121115) (b)(4).
Event or Problem Description
The patient came in for a revision of a posterior fusion of l3-s1, 9 months after primary.The screws were loose.The cause is unknown.The surgeon removed the screws and rods.After the case the agent noticed that 3 set screws of the l3-l4 screw were broken.It is unknown if the screws broke while in the patient or upon removal.The surgeon implanted another company's product.The surgery was completed successfully.Fusion was achieved in 2 vertebra yet not achieved at l5-s1.

• Brand Name: PEDICLE SCREW 7X50
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7292581
• Report Number: 3005180920-2018-00097
• Device Sequence Number: 1249910
• Product Code: KWP
• UDI-Device Identifier: 07630030834301
• UDI-Public: 07630030834301
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2018

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: 09/27/2021
• Device Catalogue Number: 03.50.032
• Device Lot Number: 165260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 02/23/2018
• 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: 38 YR