MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW MUST STRAIGHT CROSS CONNECTOR 20MM

Catalog Number	03.56.403
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 30 august 2019.Lot 1821436: (b)(4) items manufactured and released on 16-nov-2018.Expiration date: 01-11-2023.No anomalies found related to the problem.To date, 1 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Spinal fixation performed at t4-t8.The surgeon had a plan to set 3 connectors.The surgeon was not able to set the must straight cross connector at t4-t5 because both hooks of the must straight cross connector contacted to the facet joint.Other 2 connectors were used for other intervertebral level.They contacted to the facet joint too, but the surgeon was able to set the must straight cross connector.10 minutes of delay reported.Total surgery time about 4 hours.

• Brand Name: PEDICLE SCREW MUST STRAIGHT CROSS CONNECTOR 20MM
• Common Device Name: CROSS CONNECTOR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9069328
• Report Number: 3005180920-2019-00783
• Device Sequence Number: 16791585
• Product Code: KWP
• UDI-Device Identifier: 07630040705844
• UDI-Public: 07630040705844
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2019

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: 11/01/2023
• Device Catalogue Number: 03.56.403
• Device Lot Number: 1821436
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/16/2019
• 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
• Patient Age: 68 YR