PIONEER SURGICAL TECHNOLOGY, INC STREAMLINE OCT OCCIPTIO-CERVICO-THORACIC SYSTEM

Report

• Report Number: 1833824-2019-00032
• Event Type: Malfunction
• Date Received: November 11, 2019
• Date of Event: September 20, 2018
• Report Date: November 11, 2019
• Manufacturer: PIONEER SURGICAL TECHNOLOGY, INC DBA RTI SURGICAL
• Product Code: NKG
• PMA / PMN Number: K172139
• Product Problem: Yes
• Report Source: Manufacturer report
• Reporter Location: MN, US
• Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT CAME IN DURING A REVIEW OF CLINICAL DATA. PATIENT DEMOGRAPHICS HAVE NOT BEEN DISCLOSED TO RTI SURGICAL AS OF DATE OF THIS REPORT. THE SCREW IS IMPLANTED IN THE PATIENT AS OF DATE OF THIS REPORT, THEREFORE A BATCH NUMBER HAS NOT BEEN IDENTIFIED AND FURTHER INVESTIGATION IS NOT POSSIBLE. NO MORE INFORMATION IS AVAILABLE AT THIS TIME. A DHR REVIEW WAS NOT ABLE TO BE DONE BECAUSE THE DEVICE IS STILL IMPLANTED AND BATCH NUMBER IS NOT AVAILABLE.

Description of Event or Problem · 1

IT WAS DISCOVERED THAT A POLYAXIAL SCREW BROKE POST OPERATIVELY DUE TO A HARD FALL. INITIAL SURGICAL DATE WAS (B)(6) 2018. THE PATIENT WENT TO THE HOSPITAL AFTER A HARD FALL AND IT WAS DISCOVERED THROUGH X-RAY THAT THE PEDICLE SCREW WAS BROKEN AT T1. REVISION SURGERY HAS NOT BEEN DONE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1100536	PIONEER SURGICAL TECHNOLOGY, INC STREAMLINE OCT OCCIPTIO-CERVICO-THORACIC SYSTEM	SCREW, 3.5 X 12 MM, POLYAXIAL, CT	NKG	PIONEER SURGICAL TECHNOLOGY, INC DBA RTI SURGICAL	26-PA-40-26	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• No Consequences Or Impact To Patient

Product problems · 1

• Break

Source type · 1

• OTHER

Type of report · 1

• Initial submission