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BE-ST NIM PAK Needle Trocar

Lacey Manufacturing Company, LLC · Model PK1007 · UDI-DI 00853508002287

PDQ Prescription
10
510(k) clearances
77
Adverse events (1 deaths)
2
Recalls
56
Facilities

Description

Pedicle Access Kit Needle with Neural Integrity Monitor

Recalls

DateFirmReason
2020-06-23The Magstim Company LimitedReports that manipulation of the cable which connects the pre-amplifier to the nerve monitor, and the cable which connects the pre-amplifier to the stimulator pod, may cause damage
2020-06-10NuVasive IncThe NVM5 EMG Module kit intended for intraoperative neurophysiologic monitoring during spinal surgery contains incorrect component, part number 1715945, SSEP harness instead of the

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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.