FDA Adverse Event
Malfunction
Summary report: N
PIONEER SURGICAL TECHNOLOGY, INC STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM
MDR report key: 7773393
·
Received August 10, 2018
Report
- Report Number
- 1833824-2018-00029
- Event Type
- Malfunction
- Date Received
- August 10, 2018
- Date of Event
- July 18, 2018
- Report Date
- August 10, 2018
- Manufacturer
- PIONEER SURGICAL TECHNOLOGY, INC DBA RTI SURGICAL
- Product Code
- NKG
- PMA / PMN Number
- K172139
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICES WERE DISCARDED AT THE HOSPITAL THEREFORE A COMPLETE INSPECTION CANNOT BE CONDUCTED. THE PATIENT WAS IN RECOVERY AFTER THE SURGERY. NO MORE INFORMATION IS AVAILABLE AT THIS TIME. A DHR REVIEW WAS NOT ABLE TO BE DONE BECAUSE THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND THE BATCH NUMBER WAS NOT MADE AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED TO RTI SURGICAL THAT A POSTERIOR CERVICAL ROD BROKE POST OPERATIVELY AND WAS REPLACED DURING A REVISION SURGERY. PATIENT IS RECOVERING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 613541 | PIONEER SURGICAL TECHNOLOGY, INC STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM | 120MM POSTERIOR CERVICAL ROD | NKG | PIONEER SURGICAL TECHNOLOGY, INC DBA RTI SURGICAL | 23-CC-ROD-120 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 93 YR |