Accell Connexus 02-3000-010Recalls & reported problems
Isotis Orthobiologics, Inc. · Accell Connexus, 1cc - demineralized human bone mixed with poloxamer reverse phase medium. Accell Connexus is formulated into a putty form and is provided in a sterile, single use package · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 10889981055462), received between Nov 2, 2016 and Nov 2, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Patient-Device Incompatibility1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 2, 2016Patient-Device Incompatibility; Patient-Device Incompatibility
INITIAL ACDF SURGERY AT C5-C7 WAS PERFORMED ON (B)(6) 2016. OSTEOPHYTES WERE REMOVED TO DECOMPRESS SITE AND AUTOGRAPH WAS MIXED WITH 1 CC OF ALLOGRAFT PUTTY, AND PLACED AT THE WOUND SITE. EVENT: ON (B)(6) 2016 PATIENT INCURRED PAIN AND UNDERWENT REVISION SURGERY TO REMOVE PART OF THE 1CC PUTTY MIXED WITH AUTONOMOUS BONE. IT IS BELIEVED THAT THE GRAPH WAS PLACED ON OR NEAR THE NERVE, CAUSING NERVE IRRITATION AND PATIENT PAIN. PATIENT OUTCOME: POST-REVISION SURGERY, THE PATIENT SYMPTOMS ARE EXPECTED TO BE RELIEVED.
Patient problems: Pain
MAUDE report 6073859 ↗
Other FILLER, BONE VOID, CALCIUM COMPOUND devices
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T44150Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND3 recalls1 report
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42275Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls1 report
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42280Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls0 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42200Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls0 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T44145Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls0 reports
- MAGNIFUSE® Bone Graft 7509014Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall2 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T43102Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall2 reports
- HydroSet XT 897005Stryker Corporation · FILLER, BONE VOID, CALCIUM COMPOUND1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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