MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ROD COCR 5.5X480

Catalog Number	03.50.433
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	06/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 july 2018.Lot 144216b: (b)(4) items manufactured and released on 22 november 2017.Expiration date: 2022-10-26.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.Other device involved: pedicle screw reference 03.50.433 (k121115) rod cocr 5.5x480.Lot 148723: (b)(4) items manufactured and released on 08 may 2017.Expiration date: 2022-04-18.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 10 july 2018: in a long posterior thoraco-lumbar stabilization (diagnosis unknown, but it is likely to be a deformity case) both cocr rods fractured at l5-s1 only few weeks after surgery.The cause for such fracture is totally unknown; no traumas have been reported but the double fracture at the same level leads to suspect that an abnormal load was suffered by the construct.At such short follow up time it should be a fatigue fracture.No clinical cause for this event can be determined with the information at hand.
Event or Problem Description
The rod snapped inside the patient.It is unknown how the rod snapped.It is unknown when the revision will take place.The surgeon did not perform an osteotomy.The patient had significant blood loss and this was their 3rd surgery.That may have factored into that decision.No cage subsidence or fracture was mentioned.Patient will be revised with competitor's implants.

• Brand Name: PEDICLE SCREW ROD COCR 5.5X480
• Common Device Name: ROD COCR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7685636
• Report Number: 3005180920-2018-00501
• Device Sequence Number: 18991103
• Product Code: KWP
• UDI-Device Identifier: 07630030835445
• UDI-Public: 07630030835445
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2018

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: 10/26/2022
• Device Catalogue Number: 03.50.433
• Device Lot Number: 144216B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 07/13/2018
• 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: 65 YR