RegenerOss RGP1020Recalls & reported problems

Collagen Matrix, Inc. · Bone Graft Plug · Class 2 · Implant

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813954025322), received between Sep 3, 2024 and Sep 3, 2024 — classified as 1 injury.

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

Adverse Event Without Identified Device or Use Problem1

Patient problems

Inflammation1
Pain1
Swelling/ Edema1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED THE ZIMVIE REGENEROSS BONE PLUG WAS USED ON A PATIENT AFTER TOOTH #6 WAS EXTRACTED ON (B)(6) 2024. PATIENT EXHIBITED INFLAMMATION, PAIN AND SWEATING. REVISION SURGERY PERFORMED ON (B)(6) 2024 AND THE ZIMVIE BONE PLUG WAS EXTRACTED DURING THE REVISION PROCEDURE. BONE, PRF (PLATELET RICH FIBRIN) AND "A SMALL MEMBRANE" (NAME OF MEMBRANE NOT PROVIDED) WAS PLACED IN THE EXTRACTION SITE DURING THE REVISION PROCEDURE. CUSTOMER CONFIRMED THE PATIENT'S DENTAL IMPLANT PLACEMENT IS DELAYED. ADDITIONAL CLARIFICATION SURROUNDING THE EVENT AND FUTURE DENTAL IMPLANT SURGERY WAS REQUESTED BUT NOT PROVIDED. NO FURTHER INFORMATION PROVIDED.
Patient problems: Inflammation; Pain; Swelling/ Edema
MAUDE report 20128583 ↗

Device details

UDI-DI	`00813954025322`
Brand	RegenerOss
Model	RGP1020
Company	Collagen Matrix, Inc.
Product code	NPM · Bone Grafting Material, Animal Source
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jan 16, 2023

Device type (GMDN): Dental bone matrix implant, synthetic

A sterile bioabsorbable device made of synthetic material implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is typically made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), sometimes bioactive glasses or bioabsorbable polymers, and used to fill bone cavities and defects to promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

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All Bone Grafting Material, Animal Source devices →

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