MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL) PIONEER SURGICAL STERNAL CABLE SYSTEM

Model Number	402-523
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The dhr and sterilization records were reviewed and the device was manufactured and sterilized to required specifications.Repeated attempts were made in order to help gather more information on this case but these attempts were unsuccessful.The patient's condition is unknown at this time.Unknown location of implants.
Event or Problem Description
Sometime after the initial surgery the patient experienced infection.The surgeon does not believe that this was caused by the sternal cables that were implanted to close the sternum.No more information was able to be gathered for this occurrence.

• Brand Name: PIONEER SURGICAL STERNAL CABLE SYSTEM
• Common Device Name: STERNAL CABLE SYSTEM
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• MDR Report Key: 6529631
• Report Number: 1833824-2017-00010
• Device Sequence Number: 614477
• Product Code: JDQ
• UDI-Device Identifier: 00846468041014
• UDI-Public: (01)00846468041014(17)211213(10)264789
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K935481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 12/13/2021
• Device Model Number: 402-523
• Device Catalogue Number: SAME
• Device Lot Number: 264789
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2017
• Initial Report FDA Received Date: 04/28/2017
• 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