BioHorizons PGRSCRecalls & reported problems

Biohorizons Implant Systems, Inc · Snap Coping, 4.5mm, Regular · Class 1 · Implant

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847236005375), received between May 8, 2024 and May 8, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fracture2

Patient problems

Insufficient Information2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 8, 2024Fracture; Fracture
FRACTURED ITEM.
Patient problems: Insufficient Information
MAUDE report 19268917 ↗
MalfunctionMay 8, 2024Fracture; Fracture
IMPRESSION COPING WAS DAMAGED/BENT DURING THE PROCESS OF TAKING AN IMPRESSION.
Patient problems: Insufficient Information
MAUDE report 19268915 ↗

Device details

UDI-DI	`00847236005375`
Brand	BioHorizons
Model	PGRSC
Company	Biohorizons Implant Systems, Inc
Product code	NDP · Accessories, Implant, Dental, Endosseous
Class	Class 1
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 28, 2020

Device type (GMDN): Dental implant suprastructure, temporary, preformed, single-use

A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.