MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ROD TI 5.5X200

Catalog Number	03.50.401
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Weakness (2145)
Date of Event	02/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on 02 march 2018: rod fracture in lumbar spine stabilization with pedicle screws.According to report, the patient probably suffered a traumatic event that caused fracture of l5 and a reoperation.A couple of months later, the longitudinal rod was found broken and replaced.From the information available, no fusion took place between l4 and l5.In absence of fusion, the temporary stabilization devices may fail because they cannot be dimensioned for long-term performance if unsupported by bony structures.The available documentation does not allow further conclusions to be drawn.Batch review performed on 16 march 2018: lot 144733: 200 items manufactured and released on 18 november 2014; expiration date: 2019-10-23.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported issue.
Event or Problem Description
Revision surgery performed due to pain probably caused by a rod breakage 1 year and 2 months after primary.The surgeon revised 2 rods and 6 screws.He re-implanted at l2-pelivis.The patient had a primary on 8 (b)(6) 2016.On (b)(6) 2016 the patient fractured at l5, and was having pain and weakness, surgeon removed one interbody one 7x45 pedicle screw and two rods.(mdr 2016-00754).On (b)(6) 2018 the patient came in complaining of pain.The cause of pain was not determined.

• Brand Name: PEDICLE SCREW ROD TI 5.5X200
• Common Device Name: ROD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7345188
• Report Number: 3005180920-2018-00161
• Device Sequence Number: 16649927
• Product Code: KWP
• UDI-Device Identifier: 07630030835346
• UDI-Public: 07630030835346
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2018

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: Other
• Device Expiration Date: 10/23/2019
• Device Catalogue Number: 03.50.401
• Device Lot Number: 144733
• 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: 02/16/2018
• Initial Report FDA Received Date: 03/16/2018
• 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: 74 YR