MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) TRITIUM CABLE PLATE SYSTEM; CABLE PLATE SYSTEM SCREW,

Model Number 86-27-14

Device Problems Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 06/24/2018

Event Type  Death  

Manufacturer Narrative

As of the date of this report, the device has not been returned to rti surgical for evaluation.A dhr review was conducted and confirms that the device met manufacturing specifications prior to shipping from rti surgical.If the device or additional information become available at a later date, this report will be updated.

Event Description

It was reported to rti surgical quality systems department on (b)(6) 2021 that a sternal fixation revision surgery was conducted after the patient presented with symptoms consistent with a nickel allergy following the index surgery.Index surgery was on (b)(6) 2018.Revision surgery was on (b)(6) 2018.The patient subsequently died in (b)(6) 2019.Exact date of death is unknown.

• Brand Name: TRITIUM CABLE PLATE SYSTEM
• Type of Device: CABLE PLATE SYSTEM SCREW,
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer Contact: daniel nelson ; 375 river park circle; marquette, MI 49855 ; 9062269909
• MDR Report Key: 11407585
• MDR Text Key: 234545589
• Report Number: 1833824-2021-00030
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 86-27-14
• Device Catalogue Number: SAME
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention