Device manufacturer, as written on reports

Depuy Spine: medical device reports filed with FDA

10,567 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.

10,567
reports naming it as manufacturer: 0% of all MAUDE reports; 1,330
reports, 12 months to August 2026: 1,227 in the 12 months before; 78.8%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

10,567 medical device reports received by FDA give Depuy Spine as the manufacturer of the device involved, 0% of the MAUDE database, from October 2003 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

1,330 reports arrived in the 12 months to August 2026, close to the 1,227 of 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 malfunction (78.8%), injury (20.7%) and death (0.2%). 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
Verse X25 Inserter/Tightener	Driver, prosthesis	530	87	0%
X25 Final Tightener	Driver, prosthesis	417	15	0%
Xpdm Quick-Con Si Poly Scwdrvr	Screwdriver	353	13	0%
Viper2 Final Tightener Driver	Driver, prosthesis	183	22	0%
Charite Artificial Disc Size Unknown	Prosthesis, intervertebral disc	161	0	1.2%
Moss Miami Spine System Hexlobe Driver 5 5 X25	Driver, prosthesis	156	0	0%
Expedium Spine System Quick Connect Si Poly Driver	Screwdriver	149	1	0%
Expedium Verse Spine System Inserter/Tightener X25	Driver, prosthesis	147	2	0%
Torque wrench	Wrench	146	13	0%
Viper Universal Poly Driver	Screwdriver	139	3	0%
Expedium	Thoracolumbosacral pedicle screw system	120	235	0%
Symphony	Pulse generator, permanent, implantable	106	133	1.6%
Expedium Verse	Driver, prosthesis	103	127	0%
Confidence Spinal Cmt Sys 11c	Cement, bone, vertebroplasty	70	14	1.8%
Unknown Screws	Screw, fixation, bone	68	23	1.7%
Confidence Kit No Needles	Cement, bone, vertebroplasty	60	8	5.1%
Verse Correction Key	Thoracolumbosacral pedicle screw system	43	3	0%
Unknown Cage/Spacer	Intervertebral fusion device with integrated fixation, lumbar	37	4	0%
5 5 Exp Verse Unitized Set Scr	Thoracolumbosacral pedicle screw system	25	11	0%
Unknown Mono/Polyaxial Screws	Thoracolumbosacral pedicle screw system	17	0	0%
Unknown Rods	Thoracolumbosacral pedicle screw system	13	9	1.1%
Unknown Screw/Rod Construct Accessories	Orthosis, spondylolisthesis spinal fixation	13	0	0%
Single-Inner Setscrew	Thoracolumbosacral pedicle screw system	5	19	0%
Mmsi Final Tightener	Driver, prosthesis	2	0	0%
Depuy	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	1	9	1.8%

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
HWR	Driver, prosthesis	2,810	26.6%
LXH	Orthopedic manual surgical instrument	1,572	14.9%
HXX	Screwdriver	1,293	12.2%
NKB	Thoracolumbosacral pedicle screw system	588	5.6%
OLO	Orthopedic stereotaxic instrument	581	5.5%
MJO	Prosthesis, intervertebral disc	547	5.2%
KWQ	Appliance, fixation, spinal intervertebral body	325	3.1%
NDN	Cement, bone, vertebroplasty	232	2.2%
MAX	Intervertebral fusion device with bone graft, lumbar	230	2.2%
HXC	Wrench	172	1.6%

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

Death0.2%17

Injury20.7%2,186

Malfunction78.8%8,332

Other0.1%6

Not given0.2%26

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

Questions about Depuy Spine reports

How many FDA device reports name Depuy Spine as manufacturer?

10,567 reports through August 2026, 1,330 of them in the latest 12 months.

Which of its brands appear most often?

Verse X25 Inserter/Tightener (530), X25 Final Tightener (417), Xpdm Quick-Con Si Poly Scwdrvr (353), Viper2 Final Tightener Driver (183) and Charite Artificial Disc Size Unknown (161).

Which device types does it report on?

driver, prosthesis (26.6%), orthopedic manual surgical instrument (14.9%), screwdriver (12.2%) and thoracolumbosacral pedicle screw system (5.6%).

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.