inforMED
NQWClass IIImplant

Orthosis, Spine, Plate, Laminoplasty, Metal

Orthopedic · 21 CFR 888.3050

This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.

MDR events202All time
Recalls0All time
Registered firms119Currently listed
510(k) clearances30All time

Recent MDR events

202 adverse event reports on file

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Event type breakdown

Malfunction127
Injury75

Most-reported manufacturers

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Synthes (usa)39Warsaw Orthopedics33Mdt Sofamor Danek Puerto Rico Mfg22Mdt Puerto Rico Operations Co, Med Rel15Zimmer Biomet Spine Inc.12Aesculap Ag9Synthes Usa9Xtant Medical Holdings, Inc.9

Product problems

Reported product problem codes, most common first

Break47
Adverse Event Without Identified Device or Use Problem31
Device Operates Differently Than Expected18
Human-Device Interface Problem17
Migration or Expulsion of Device13
Device Markings/Labelling Problem12
Expiration Date Error9
Insufficient Device Problem Information9

Trend for “Break”

01020May 24Sep 24Jan 25May 25Sep 25Jan 26May 26

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

119 firms currently registered for this product code

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510(k) clearances

30 clearances for this product code

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