FDA Adverse Event
Malfunction
Summary report: N
HAMMERTUBE SYSTEM
MDR report key: 14739599
·
Received June 17, 2022
Report
- Report Number
- 3008640117-2022-00066
- Event Type
- Malfunction
- Date Received
- June 17, 2022
- Date of Event
- May 20, 2022
- Report Date
- June 17, 2022
- Manufacturer
- PARAGON 28, INC.
- Product Code
- HTY
- PMA / PMN Number
- K171715
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
NONCONFORMING PRODUCTS WERE FOUND IN A CASE WHERE THE TITANIUM PLASMA COATING WAS MISSING ON IMPLANTS. NO PATIENT IMPACT WAS REPORTED AND THE IMPLANTS WERE NOT USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1350569 | HAMMERTUBE SYSTEM | HAMMERTUBE IMPLANT, 2.75MM, 10° CANNULATED | HTY | PARAGON 28, INC. | P40-002-0275-S | 26010822202 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |