PRODISC C MILLING BIT 03.820.167

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for PRODISC C MILLING BIT 03.820.167 manufactured by Centinel Spine Llc.

Event Text Entries

[181527642] Pt admitted for elective surgery of a cervical five-cervical six discectomy and disc replacement. Prior to the placement of the prodisc-c cervical implant, the milling bit tip broke (approx 16mm in length). Lateral x-rays were normal, anterior-posterior (ap) x-rays (c-arm) revealed metallic milling bit piece inferior of the cervical 6 vertebrae midline. The cervical cage implant was removed and surgeon retrieved the milling bit piece. The procedure was then converted to a cervical 5-cervical six fusion. A dural tear was noted during surgery but it is unk if the broken milling bit had caused the tear. Surgeon repaired the tear. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093297
MDR Report Key9754080
Date Received2020-02-25
Date of Report2020-02-21
Date of Event2020-02-06
Date Added to Maude2020-02-26
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRODISC C MILLING BIT
Generic NamePROSTHESIS, INTEBERTEBRAL DISC
Product CodeMJO
Date Received2020-02-25
Model Number03.820.167
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCENTINEL SPINE LLC
Manufacturer AddressWEST CHESTER PA 19380 US 19380


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2020-02-25

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