MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW REDUCTION CANNULATED PEDICLE SCREW 6X40

Catalog Number	03.52.717
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2019: lot 1820210: 60 items manufactured and released on 13-apr-2018.Expiration date: 2023-03-25.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been already sold without any similar reported event.Patient match planning review performed by myspine department as per your request, we analyzed each step of the myspine process.Images qc: the images we received were subjected to quality control, the result of which was positive.Reconstruction: the reconstruction is precise and correct, all areas were clearly identifiable.The surgeon validated our first planning proposal.The screws were planned in order to guarantee the safety distance between the tips of the screws and the cortical bone.In this case the "cortical gap" is 5mm.L04 guide -> the guide was designed according to the trajectory of the screws in the planning validated (rev.0).Conclusions our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.
Event or Problem Description
Revision surgery performed 2 days after the primary due to pain due to radiculopathy.The surgeon revised the 40mm pedicle screw at l4, with a 35mm pedicle screw and the surgery was completed successfully.

• Brand Name: PEDICLE SCREW REDUCTION CANNULATED PEDICLE SCREW 6X40
• Common Device Name: REDUCTION CANNULATED PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8669900
• Report Number: 3005180920-2019-00432
• Device Sequence Number: 19362283
• Product Code: NKB
• UDI-Device Identifier: 07630030847134
• UDI-Public: 07630030847134
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K153664
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2019

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: 03/25/2023
• Device Catalogue Number: 03.52.717
• Device Lot Number: 1820210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 06/05/2019
• 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: 56 YR