Device manufacturer, as written on reports

Medtronic Sofamor Danek: medical device reports filed with FDA

4,520 reports name it as the manufacturer of the device involved, 2000–2026.

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.

4,520
reports naming it as manufacturer: 0% of all MAUDE reports; 6
reports, 12 months to August 2026: 7 in the 12 months before; 40%
classified as malfunction: 62.3% across all reports; 0.8%
classified as death, as reported: 0.9% across all reports

4,520 medical device reports received by FDA give Medtronic Sofamor Danek as the manufacturer of the device involved, 0% of the MAUDE database, from April 2000 to June 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

6 reports arrived in the 12 months to August 2026, down 14% from 7 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 (40%) and other (0.9%). 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
CD HORIZON Spinal System	Appliance, fixation, spinal interlaminal	1,101	634	0.3%
Manual Orthopedic Surgical Instrument	Orthopedic manual surgical instrument	649	0	0.1%
Infuse Bone Graft	Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction	163	36	0.3%
Tsrh Spinal System	Appliance, fixation, spinal interlaminal	129	0	0.4%
ATLANTIS Anterior Cervical Plate System	Appliance, fixation, spinal intervertebral body	116	18	1.6%
Vertex Reconstruction System	Appliance, fixation, spinal interlaminal	106	9	0.3%
Clydesdale Spinal System	Intervertebral fusion device with bone graft, lumbar	69	33	0.4%
Orthopedic Manual Surgical Instrument	Orthopedic manual surgical instrument	59	0	0.2%
Bryan Cervical Disc System	Prosthesis, intervertebral disc	55	0	0.4%
Venture Anterior Cervical Plate System	Appliance, fixation, spinal intervertebral body	47	4	0.5%
Kyphx Hv-R Bone Cement	Cement, bone, vertebroplasty	43	7	3.4%
Cd Horizon	Appliance, fixation, spinal interlaminal	38	38	0.3%
PRESTIGE Cervical Disc System	Prosthesis, intervertebral disc	32	20	0.4%
Verte-Stack Spinal System	Spinal vertebral body replacement device	27	0	0.5%
CAPSTONE Spinal System	Intervertebral fusion device with bone graft, lumbar	22	26	0.3%
Unknown Screw	Screw, fixation, bone	11	156	0%
Kyphon Xpander Inflatable Bone Tamp	Arthroscope	10	22	0%
Zevo Anterior Cervical Plate System	Appliance, fixation, spinal intervertebral body	10	13	0.6%
CLYDESDALE PTC Spinal System	Intervertebral fusion device with bone graft, lumbar	7	5	0%
Metrx	Orthopedic manual surgical instrument	7	3	0%
ELEVATE Spinal System	Intervertebral fusion device with bone graft, lumbar	6	46	0%
Crescent Spinal System	Intervertebral fusion device with bone graft, lumbar	5	5	0.6%
Medtronic	Implantable cardioverter defibrillator (non-crt)	4	17	4.4%
METRx System	Orthopedic manual surgical instrument	4	267	0.1%
CD HORIZON SOLERA Spinal System	Thoracolumbosacral pedicle screw system	3	68	0%
Screw	Screw, fixation, bone	3	0	0%
Unk Screw	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	3	63	0%
X-Stop Ipd System	Prosthesis, spinous process spacer/plate	3	0	0.8%
Catalyft PL Expandable Interbody System	Intervertebral fusion device with bone graft, lumbar	2	95	0%
Divergence Anterior Cervical Fusion System	Intervertebral fusion device with integrated fixation, cervical	2	30	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
KWP	Appliance, fixation, spinal interlaminal	1,289	28.5%
LXH	Orthopedic manual surgical instrument	634	14%
NKB	Thoracolumbosacral pedicle screw system	400	8.8%
NDN	Cement, bone, vertebroplasty	388	8.6%
KWQ	Appliance, fixation, spinal intervertebral body	362	8%
NEK	Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction	261	5.8%
HRX	Arthroscope	224	5%
MAX	Intervertebral fusion device with bone graft, lumbar	198	4.4%
HXX	Screwdriver	153	3.4%
MJO	Prosthesis, intervertebral disc	96	2.1%

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

Death0.8%38

Injury57.3%2,591

Malfunction40%1,808

Other0.9%42

Not given0.9%41

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 reports

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

4,520 reports through August 2026, 6 of them in the latest 12 months.

Which of its brands appear most often?

CD HORIZON Spinal System (1,101), Manual Orthopedic Surgical Instrument (649), Infuse Bone Graft (163), Tsrh Spinal System (129) and ATLANTIS Anterior Cervical Plate System (116).

Which device types does it report on?

appliance, fixation, spinal interlaminal (28.5%), orthopedic manual surgical instrument (14%), thoracolumbosacral pedicle screw system (8.8%) and cement, bone, vertebroplasty (8.6%).

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.