FDA Adverse Event
Malfunction
Summary report: N
4.0 X 40MM SCREW SUPER FASTENER, ST
MDR report key: 18288423
·
Received December 7, 2023
Report
- Report Number
- 3011656326-2023-00004
- Event Type
- Malfunction
- Date Received
- December 7, 2023
- Date of Event
- June 14, 2021
- Report Date
- December 7, 2023
- Manufacturer
- OSTEOCENTRIC TECHNOLOGIES, INC.
- Product Code
- HWC
- UDI-DI
- 00810074300148
- PMA / PMN Number
- K150981
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
UDI RELEATED DATA QUALITY UPDATES, PRODUCT INFORMATION UPDATE, INITIAL REPORTER UPDATES, & REPORT SOURCE UPDATE: THIS FOLLOW-UP REPORT INCLUDES THE ADDITION OF THE BRAND NAME, MODEL NUMBER, AND FULL UDI, WHICH WERE MISSING FROM THE INITIAL REPORT. ADDITIONALLY, THIS REPORT UPDATES THE INITIAL REPORTER INFORMATION TO THE PHYSICIAN WHO INITIALLY REPORTED THE ISSUE AND INCLUDES THE REPORT SOURCE OF HOW THE ISSUE BECAME KNOWN BY OSTEOCENTRIC TECHNOLOGIES, INC.
Description of Event or Problem · 0
A PROX HUM FASTENER BACKED OUT OF THE PATIENT AND THE PLATE. THE ORIGINAL SURGERY OCCURED ON (B)(6) 2021. THE PATIENT HAD HEALED AND THE FASTENER WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 198032 | 4.0 X 40MM SCREW SUPER FASTENER, ST | 4.0MM X 40MM FASTENER | HWC | OSTEOCENTRIC TECHNOLOGIES, INC. | 340-2040 | 00810074300148 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female | Other |