MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF TRANSFORAMINAL INSERTER; REUSABLE SURGICAL INSTRUMENT FOR SPINE

Catalog Number 03.22.10-0065

Device Problems Bent (1059); Malposition of Device (2616); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2014

Event Type  malfunction  

Event Description

During the insertion of a transforaminal cage in a two level tlif case, the transforaminal inserter got bent.Due to the deformation the surgeon was not able to couple the instrument with the implant anymore and he left the implant at its final position without being able to reposition the cage.The surgeon was not completely satisfied with the final position of the implant.Mfr: 3005180920-2014-00093.

• Brand Name: MECTALIF TRANSFORAMINAL INSERTER
• Type of Device: REUSABLE SURGICAL INSTRUMENT FOR SPINE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; castel san pietro ; SZ
• Manufacturer (Section G): MEDACTA USA INC.; 1556 w carroll ave; chicago IL 60607 000
• Manufacturer Contact: 1556 w carroll ave; chicago, IL 60607-0000
• MDR Report Key: 4543675
• MDR Text Key: 18035938
• Report Number: 3006639916-2014-00093
• Device Sequence Number: 1
• Product Code: KWP
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/25/2014

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.22.10-0065
• Device Lot Number: 1112401A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2014
• Distributor Facility Aware Date: 07/15/2014
• Device Age: 22 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other