Device manufacturer, as written on reports

Synthes Hagendorf: medical device reports filed with FDA

2,657 reports name it as the manufacturer of the device involved, 2012–2017.

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.

2,657
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 85.2%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

2,657 medical device reports received by FDA give Synthes Hagendorf as the manufacturer of the device involved, 0% of the MAUDE database, from March 2012 to December 2017. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

0 reports arrived in the 12 months to August 2026, and none 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 malfunction (85.2%), injury (14.7%) and death (0.1%). 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
Application Instrument For Sternal Zipfix	Cerclage, fixation	239	4	0%
T-Pal Spacer Applicator Inner Shaft	Intervertebral fusion device with bone graft, lumbar	148	0	0%
Inserter For Ti Elastic Nails	Orthopedic manual surgical instrument	129	1	0%
T-Pal Spacer Applicator Handle	Intervertebral fusion device with bone graft, lumbar	80	0	0%
Standard Insertion Handle	Orthopedic manual surgical instrument	75	0	0%
T-Pal Spacer Applicator Knob	Intervertebral fusion device with bone graft, lumbar	75	0	0%
Dhs/Dcs Coupling Screw	Extractor	55	12	0%
130 Deg Aiming Arm F/Trochanteric Fixation Nails	Guide, surgical, instrument	42	0	0%
Buttress/Compression Nut	Orthopedic manual surgical instrument	33	32	0%
Synframe Ring Clamp	Orthopedic manual surgical instrument	30	0	0%
Cannulated Connecting Screw	Rod, fixation, intramedullary and accessories	21	27	0%
5mm Hex Flexible Screwdriver	Orthopedic manual surgical instrument	18	60	0.2%
Cannulated 4 0mm Hexagonal Screwdriver	Screwdriver	17	9	0%
Small Hexagonal Screwdriver With Holding Sleeve	Screwdriver	7	0	0%
Universal Chuck With T-Handle	Orthopedic manual surgical instrument	7	9	0%
Depth Gauge For 2 7mm & Small Screws	Gauge, depth	6	5	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
LXH	Orthopedic manual surgical instrument	791	29.8%
HXX	Screwdriver	391	14.7%
FZX	Guide, surgical, instrument	353	13.3%
JDQ	Cerclage, fixation	247	9.3%
MAX	Intervertebral fusion device with bone graft, lumbar	177	6.7%
HSB	Rod, fixation, intramedullary and accessories	156	5.9%
HWT	Template	62	2.3%
OVE	Intervertebral fusion device with integrated fixation, cervical	51	1.9%
HWB	Extractor	47	1.8%
HTJ	Gauge, depth	46	1.7%

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

Death0.1%3

Injury14.7%390

Malfunction85.2%2,264

Other0%0

Not given0%0

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

Questions about Synthes Hagendorf reports

How many FDA device reports name Synthes Hagendorf as manufacturer?

2,657 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Application Instrument For Sternal Zipfix (239), T-Pal Spacer Applicator Inner Shaft (148), Inserter For Ti Elastic Nails (129), T-Pal Spacer Applicator Handle (80) and Standard Insertion Handle (75).

Which device types does it report on?

orthopedic manual surgical instrument (29.8%), screwdriver (14.7%), guide, surgical, instrument (13.3%) and cerclage, fixation (9.3%).

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.