FDA Device Intelligence
HomeMedacta International SA › M.U.S.T. Pedicle Screw System

M.U.S.T. Pedicle Screw System

Medacta International SA · Model 03.61.386 · UDI-DI 07630345708557

PML Prescription
1
510(k) clearances
310
Adverse events (8 deaths)
2
Recalls
80
Facilities

Description

Fenestrated polyax. cann. ped. scr.10x35,dual-diam

Recalls

DateFirmReason
2023-11-28Icotec Agicotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected th
2023-11-28Icotec Agicotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected th

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.