Device manufacturer, as written on reports

Medtronic Sofamor Danek USA: medical device reports filed with FDA

24,350 reports name it as the manufacturer of the device involved, 2003–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

24,350
reports naming it as manufacturer: 0.1% of all MAUDE reports; 2,175
reports, 12 months to August 2026: 2,820 in the 12 months before; 42%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

24,350 medical device reports received by FDA give Medtronic Sofamor Danek USA as the manufacturer of the device involved, 0.1% of the MAUDE database, from March 2003 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

2,175 reports arrived in the 12 months to August 2026, down 23% from 2,820 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (57.3%), malfunction (42%) and death (0.3%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Infuse Bone Graft	Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction	11,875	36	0.3%
METRx System	Orthopedic manual surgical instrument	1,651	267	0.1%
CD HORIZON Spinal System	Appliance, fixation, spinal interlaminal	1,601	634	0.3%
Orthopedic Manual Surgical Instrument	Orthopedic manual surgical instrument	619	0	0.2%
CD HORIZON SOLERA VOYAGER Spinal System	Thoracolumbosacral pedicle screw system	490	216	0.1%
Manual Orthopedic Surgical Instrument	Orthopedic manual surgical instrument	490	0	0.1%
Cd Horizon Solera 5 5/6 0	Screwdriver	463	131	0%
T2 STRATOSPHERE Expandable Corpectomy System	Spinal vertebral body replacement device	313	43	0.3%
Metrx	Orthopedic manual surgical instrument	309	3	0%
Screwdriver	Screwdriver	301	15	0%
METRx(TM) System	Arthroscope	265	113	0%
Pivox Oblique Lateral Spinal System	Intervertebral fusion device with bone graft, lumbar	208	5	0%
Powerease Instruments	Drills, burrs, trephines & accessories (simple, powered)	184	11	0%
KYPHON HV-R Bone Cement	Cement, bone, vertebroplasty	176	110	0.3%
CD Horizon Ballast Spinal System	Thoracolumbosacral pedicle screw system	155	20	0%
ELEVATE Spinal System	Intervertebral fusion device with bone graft, lumbar	131	46	0%
KYPHON Xpede Bone Cement	Cement, bone, vertebroplasty	107	38	3%
McGRATH	Laryngoscope, rigid	79	89	1.8%
Kyphx Hv-R Bone Cement	Cement, bone, vertebroplasty	69	7	3.4%
CAPSTONE Spinal System	Intervertebral fusion device with bone graft, lumbar	60	26	0.3%
Clydesdale Spinal System	Intervertebral fusion device with bone graft, lumbar	45	33	0.4%
Infinity	Implant, endosseous, root-form	41	24	2.1%
Vertex Reconstruction System	Appliance, fixation, spinal interlaminal	27	9	0.3%
Crescent Spinal System	Intervertebral fusion device with bone graft, lumbar	24	5	0.6%
ATLANTIS Anterior Cervical Plate System	Appliance, fixation, spinal intervertebral body	23	18	1.6%
INFINITY Occipitocervical Upper Thoracic System	Appliance, fixation, spinal interlaminal	15	19	0%
Catalyft PL Expandable Interbody System	Intervertebral fusion device with bone graft, lumbar	13	95	0%
Bryan Cervical Disc System	Prosthesis, intervertebral disc	9	0	0.4%
Cd Horizon	Appliance, fixation, spinal interlaminal	9	38	0.3%
Kyphon Xpander Inflatable Bone Tamp	Arthroscope	8	22	0%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product code	Device type	Reports	Share
NEK	Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction	12,001	49.3%
LXH	Orthopedic manual surgical instrument	3,776	15.5%
HXX	Screwdriver	2,013	8.3%
HRX	Arthroscope	1,100	4.5%
NKB	Thoracolumbosacral pedicle screw system	842	3.5%
MAX	Intervertebral fusion device with bone graft, lumbar	815	3.3%
KWP	Appliance, fixation, spinal interlaminal	714	2.9%
MQP	Spinal vertebral body replacement device	546	2.2%
NDN	Cement, bone, vertebroplasty	491	2%
OLO	Orthopedic stereotaxic instrument	321	1.3%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0.3%84

Injury57.3%13,964

Malfunction42%10,231

Other0.1%20

Not given0.2%51

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Medtronic Sofamor Danek USA reports

How many FDA device reports name Medtronic Sofamor Danek USA as manufacturer?

24,350 reports through August 2026, 2,175 of them in the latest 12 months.

Which of its brands appear most often?

Infuse Bone Graft (11,875), METRx System (1,651), CD HORIZON Spinal System (1,601), Orthopedic Manual Surgical Instrument (619) and CD HORIZON SOLERA VOYAGER Spinal System (490).

Which device types does it report on?

filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction (49.3%), orthopedic manual surgical instrument (15.5%), screwdriver (8.3%) and arthroscope (4.5%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.