InjuryPLF
TITAN 3-D WEDGE SYSTEM
Received Nov 17, 2022 · Event occurred Sep 10, 2019
Report 3008650117-2022-00135 · MDR key 15820538
Device
Generic name
Cotton Wedge
Manufacturer
Paragon 28, IncModel number
P03-COT-1006-SCatalog number
P03-COT-1006-S
Product problems
- Malposition of Device
- Malposition of Device
Patient
39 YR · Male
- Implant Pain
- Implant Pain
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
POST MARKET FOLLOW-UP CLINICAL STUDY RECEIVED. IMPLANT LOOSENED POST-OPERATIVE DURING PATIENT USE.