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

Catalog Number	03.56.402
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 8 august 2019: lot 1821264: (b)(4) items manufactured and released on 25-jul-2018.Expiration date: 2023-07-08.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.Visual inspection performed by medacta spine r&d project manager: the cross connector, ref.03.56.402, lot.1821264, analyzed is according to the specification and the functionality is guaranteed.The difficulties in the implant assembling is probably the impingement with the bone structure.
Event or Problem Description
The surgeon was not able to set the straight cross connector to the rod, because the connection part with rod was narrow, thick and the straight cross connector was in contact with the bone around the rod.The surgeon finished the surgery without using the straight cross connector.Due to this event, the surgery was prolonged about 10 minutes.

• Brand Name: PEDICLE SCREW MUST STRAIGHT CROSS CONNECTOR 20MM
• Common Device Name: SPINE IMPLANT CROSS CONNECTOR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8959079
• Report Number: 3005180920-2019-00728
• Device Sequence Number: 2860096
• Product Code: KWP
• UDI-Device Identifier: 07630040705837
• UDI-Public: 07630040705837
• 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): 09/04/2019

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: 07/08/2023
• Device Catalogue Number: 03.56.402
• Device Lot Number: 1821264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 09/04/2019
• 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