FDA Adverse Event
Malfunction
Summary report: N
CLAMP SPINOUS PROCESS SHORT
MDR report key: 8570807
·
Received May 1, 2019
Report
- Report Number
- 1723170-2019-02101
- Event Type
- Malfunction
- Date Received
- May 1, 2019
- Date of Event
- April 26, 2019
- Report Date
- May 29, 2019
- Manufacturer
- MEDTRONIC NAVIGATION, INC
- Product Code
- OLO
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
LOT NUMBER SHOULD HAVE BEEN PROVIDED IN THE INITIAL REPORT: LOT NUMBER: 160325. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
MEDTRONIC RECEIVED INFORMATION FROM A SPD MANAGER REGARDING A NAVIGATION INSTRUMENT OUTSIDE OF A PROCEDURE. THE CALLER INDICATED THAT THE SITE DAMAGED THEIR SPINE CLAMP SO THE INSTRUMENT WAS PLANNED TO BE REPLACED. THERE WAS NO PATIENT INVOLVED WITH THIS ISSUE.
Description of Event or Problem · 1
IT WAS NOTED THAT THE DAMAGED INSTRUMENT WILL NOT TIGHTEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 362431 | CLAMP SPINOUS PROCESS SHORT | ORTHOPEDIC STEREOTAXIC INSTRUMENT | OLO | MEDTRONIC NAVIGATION, INC | 9734716 | 160325 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |