MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST MINI MONOAXIAL SCREW 5X40MM; SPINE CERVICAL PEDICLE SCREW

Catalog Number	03.50.233
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 19 august 2019: lot 152470: (b)(4), expiration date: 2020-08-17.No anomalies found related to the problem.To date, (b)(4) of the same lot have been already sold without any similar reported event.
Event or Problem Description
During the primary spine surgery, and while the surgeon was reducing the rod, the inside of the mono screw stripped.The surgeon removed the set caps and rod along with the stripped screw from the patient.The surgeon implanted a new screw and rod and replaced all the set caps in the construct and then placed the rod on the other side and completed the case.The surgery was delayed by 2 hours.The surgery was completed successfully.

• Brand Name: MUST MINI MONOAXIAL SCREW 5X40MM
• Common Device Name: SPINE CERVICAL PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8969431
• Report Number: 3005180920-2019-00751
• Device Sequence Number: 14057730
• Product Code: NKB
• UDI-Device Identifier: 07630030834981
• UDI-Public: 07630030834981
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2020
• Device Catalogue Number: 03.50.233
• Device Lot Number: 152470
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 09/06/2019
• 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: Other