Plate, fixation, bone: medical device reports filed with FDA

38,974 reports carry this product code, 1992–2026; 30 brands with a page.

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.

38,974
reports with this product code: 0.2% of all MAUDE reports; 2,117
reports, 12 months to August 2026: 2,153 in the 12 months before; 22.8%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code HRS is FDA's classification for "Plate, fixation, bone" (orthopedic panel), a class 2 device. 38,974 medical device reports carry this product code, 0.2% of the MAUDE database, from July 1992 to August 2026.

2,117 reports arrived in the 12 months to August 2026, close to the 2,153 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 injury (75.8%), malfunction (22.8%) and other (0.8%). 30 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
UNK - Constructs: Plate/Screws	752	9	0%	0.2%
Unk - Plates	488	0	0%	5.5%
Level One Thoracic	260	7	0%	9.1%
Unk - Plates Trauma	250	34	0%	29.1%
Synthes	118	0	0.6%	36.4%
Unk - Plates Spine	117	0	0%	3.9%
Ni	99	1,587	1.8%	29.5%
Level One Cmf	85	32	0%	2%
Unknown Screw	78	156	0%	11.3%
Baby Gorilla/Gorilla Plating System	60	8	0%	74.1%
Unknown Osteosynthesis Product	60	0	0%	25.3%
1.5mm Hex Driver Tip, Locking Groove	37	332	0%	93.4%
Unk Screw	28	63	0%	7.2%
Unknown_Fro_Product	27	7	0%	36.5%
3 5mm Cortex Screw Self-Tapping 14mm	20	0	0%	14.3%
ATLANTIS Anterior Cervical Plate System	18	18	1.6%	31.5%
Locking Screw	16	3	0%	17.8%
Biomet Microfixation Facial Plating System	12	0	0%	18.7%
UNK - Constructs: DHS/DCS	10	17	1.9%	0.7%
UNK - Screws: Trauma	8	288	0%	16.6%
Biomet	5	0	0.3%	20.5%
Screw	5	0	0%	14.8%
Trigen	5	0	0%	5.3%
Arthrex	4	28	0%	75.9%
Batt-Handpiece Mod F/Trs	3	0	0%	99.5%
Equinoxe	3	108	0.1%	9.8%
Fibertak	3	25	0%	90%
Depuy	2	9	1.8%	27.9%
Quick Coupling For K-Wires	2	28	0%	99.2%
Unk - Constructs Pfna	2	0	1.2%	2.4%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Synthes USA	6,076	15.6%
Synthes	5,142	13.2%
Stryker	3,058	7.8%
Oberdorf Synthes Produktions	2,887	7.4%
Biomet Microfixation	2,359	6.1%
Wrights Lane Synthes USA Products	2,316	5.9%
Acumed	2,213	5.7%
Arthrex	1,307	3.4%
Synthes Elmira	895	2.3%
Treace Medical Concepts	677	1.7%
Wright Medical Technology	610	1.6%
Zimmer	502	1.3%
Stryker Leibinger Freiburg	426	1.1%
Karl Leibinger Medizintechnik & Kg	359	0.9%
Synthes Monument	345	0.9%

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 and report source

Event type

Death0.2%73

Injury75.8%29,537

Malfunction22.8%8,892

Other0.8%310

Not given0.4%162

Who filed

Manufacturer report97.7%38,083

Voluntary report0.9%355

User facility report0%0

Distributor report0.1%37

Not given1.3%499

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	9,417	24.2%
Fracturea broken bone	2,942	7.5%
Insufficient device problem information	1,742	4.5%
Explanted	1,495	3.8%
Device-device incompatibility	1,016	2.6%
Migration or expulsion of device	912	2.3%
Device operates differently than expectedthe device behaved unexpectedly	887	2.3%
Migrationthe device moved from where it was placed	858	2.2%
Device slipped	760	2%
Device dislodged or dislocated	691	1.8%
Replace	555	1.4%
Difficult to removethe device was hard to remove	362	0.9%
Detachment of device component	351	0.9%
Fitting problem	331	0.8%
Material twisted/bent	326	0.8%
Patient device interaction problem	325	0.8%
Patient-device incompatibilitythe device did not suit the patient	313	0.8%
Bent	306	0.8%
Material deformation	287	0.7%
Loose or intermittent connection	265	0.7%

Questions about plate, fixation, bone reports

What is product code HRS?

FDA's classification code for "Plate, fixation, bone", class 2, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

38,974 reports through August 2026, 2,117 of them in the latest 12 months.

Which brands appear most often?

UNK - Constructs: Plate/Screws (752), Unk - Plates (488), Level One Thoracic (260), Unk - Plates Trauma (250) and Synthes (118). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. 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 differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.