MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY, INC. STERNAL CABLE SYSTEM; CERCLAGE, FIXATION

Catalog Number 400-689

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 07/12/2021

Event Type  malfunction  

Event Description

Sternal cable system was opened.Ref: (b)(4), lot: 373531.4 wires and 3 crimple beads were implanted.One crimple bead was defective from manufacturer, per surgeon.A second implant was opened.Ref: (b)(4), lot: 386422.One crimple bead from this implant was used.

• Brand Name: STERNAL CABLE SYSTEM
• Type of Device: CERCLAGE, FIXATION
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY, INC.; 375 river park circle; marquette MI 49855
• MDR Report Key: 12306819
• MDR Text Key: 266002366
• Report Number: 12306819
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/21/2021

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: 400-689
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6570 DA
• Patient Weight: 67