Divergence® Anterior Cervical Fusion System G6623515Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SCREW PK2 G6623515 SA S-D 3.5mm x 15mm · Class 2 · Implant

All models of Divergence Anterior Cervical Fusion System (15)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20643169338801), received between Dec 5, 2017 and May 24, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

Reports received per month

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

Most reported problems

Device problems

Device Dislodged or Dislocated1
Migration or Expulsion of Device1

Patient problems

Discomfort1
Dysphagia/ Odynophagia1

Recent adverse event reports

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

InjuryMay 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH A SCREW IN AN UNKNOWN SPINAL THERAPY FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT SCREW PULLED OUT (CAME OUT). THE PATIENT HAD DIFFICULTY SWALLOWING POSTOPERATIVELY. THE SCREW WAS PARTIALLY EXP LANTED. THE SCREW MAY NEED TO BE REPLACED. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.
Patient problems: Dysphagia/ Odynophagia
MAUDE report 19389681 ↗
InjuryDec 5, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED ON (B)(6) 2017 THE PATIENT UNDERWENT ANTERIOR CERVICAL DECOMPRESSION AND FUSION AT C4/5 DUE TO CERVICAL SPONDYLOTIC MYELOPATHY. POST-OP, AT THE TIME OF X-RAY INSPECTION OF THE ONE MONTH AFTER SURGERY, SCREW BACK OUT WAS OBSERVED. CT WAS TAKEN TO CONFIRM AND IT WAS JUDGED THAT THE SCREW HAD BACKED OUT AT CRANIAL SIDE OF C4/5. IN REVISION SURGERY, IT WAS FOUND THE LOCKING CAP WAS LOCKED, BUT THE LOCKING CAP WAS NOT PUT ON THE RELEVANT SCREW. THE SURGEON RELEASED THE LOCK MECHANISM AND TIGHTENED THE SCREW, AND THEN TURNED THE LOCKING CAP TO CONCLUDE. THE HOSPITALIZATION PERIOD WAS PROLONGED TO DUE REVISION SURGERY.
Patient problems: Discomfort
MAUDE report 7081870 ↗

Device details

UDI-DI	`20643169338801`
Brand	Divergence® Anterior Cervical Fusion System
Model	G6623515
Company	Medtronic Sofamor Danek, Inc.
Product code	OVE · Intervertebral fusion device with integrated fixation, cervical
Class	Class 2
FDA submission	K141599
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	Sep 11, 2024

Device type (GMDN): Spinal bone screw, non-bioabsorbable

A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Other Intervertebral fusion device with integrated fixation, cervical devices

NA 03.617.902
Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical
103 reports
NA 03.617.900
Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical
77 reports
Divergence® Anterior Cervical Fusion System G6626525
Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical
75 reports
Divergence® Anterior Cervical Fusion System G6626526
Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical
49 reports
NA 03.617.905
Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical
29 reports
NA 03.617.904
Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical
27 reports
Divergence® Anterior Cervical Fusion System G6626746
Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical
21 reports
NA 03.647.972
Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical
17 reports

All Intervertebral fusion device with integrated fixation, cervical devices →

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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