FDA Adverse Event
Malfunction
Summary report: N
ARTICULATING CURETTE
MDR report key: 18562207
·
Received January 23, 2024
Report
- Report Number
- 18562207
- Event Type
- Malfunction
- Date Received
- January 23, 2024
- Date of Event
- January 9, 2024
- Report Date
- January 15, 2024
- Manufacturer
- SPINEOLOGY INC.
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- LA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
DURING PROCEDURE, THE SPINEOLOGY INSTRUMENT, REF: UT 20039, HAD A SMALL PORTION OF METAL BREAK OFF AND BECOME RETAINED IN THE DISC SPACE. THE PHYSICIAN NOTICED IT AND ATTEMPTED TO RETRIEVE IT BUT WAS UNSUCCESSFUL. THE ONLY WAY HE COULD RETRIEVE IT WOULD BE A NEW LATERAL APPROACH, WHICH WOULD PROVIDE MORE RISK THAN BENEFIT PER THE PHYSICIAN. PHYSICIAN DOES NOT EXPECT IT TO CAUSE ANY ISSUES. MANUFACTURER RESPONSE FOR ARTICULATING CURETTE, (BRAND NOT PROVIDED) (PER SITE REPORTER). RETURNED IN PERSON TO SPINEOLOGY REPRESENTATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 796180 | ARTICULATING CURETTE | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | SPINEOLOGY INC. | UT20039 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19710 DA | Male |