Reported Reactions

Devices › Orthosis, spondylolisthesis spinal fixation

Device brand name · Orthosis spondylosthesis spinal fixation

Unknown Screw/Rod Construct Accessories: medical device reports filed with FDA

296 reports name it, 2019–2022. Manufacturer given most often on reports: Medos International S Rl Ch. Product code MNH.

296
device reports naming the brand
0% of all MAUDE reports · about 40 a year
0
reports, 12 months to August 2026
0 in the 12 months before
1%
classified as malfunction
35% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 296 reports that name the brand "Unknown Screw/Rod Construct Accessories" (orthosis spondylosthesis spinal fixation), received between February 2019 and October 2022; the manufacturer given most often on reports is Medos International S Rl Ch. Spellings of one product vary from report to report.

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 injury (99%) and malfunction (1%); across all orthosis, spondylolisthesis spinal fixation reports (product code MNH) death is recorded in 0% and malfunction in 35%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are break (3%), migration (2%) and corroded (1%). The patient problems coded most often are pain, nerve damage and nonunion/delayed-union bone fracture. 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."

Reports by month, five years

048Sep 2021: 6Oct 2021: 1Nov 2021: 0Dec 2021: 22022Jan 2022: 2Feb 2022: 0Mar 2022: 8Apr 2022: 0May 2022: 2Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 1Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

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

By year received

0601202019: 7520192020: 12020202021: 8820212022: 132022

Event type and report source

Event type, as classified on the report

Death0%0
Injury99%293
Malfunction1%3
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%296
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 4,393 reports carrying product code MNH. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Breakthe device broke93%21.3%
Migrationthe device moved from where it was placed62%4.4%
Corrodedthe device corroded31%0.2%
Device-device incompatibility10.3%1.3%
Material twisted/bent10.3%0.8%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)ReportsShare
Painpain, site not specified4515.2%
Nerve damage3712.5%
Nonunion/delayed-union bone fracture279.1%
Post operative wound infection268.8%
Appropriate clinical signs, symptoms and conditions term/code not available248.1%
Bone fracture(s)248.1%
Hypoesthesia237.8%
Hematomaa collection of blood under the skin or in tissue206.8%
Neurological deficit/dysfunction186.1%
Cerebrospinal fluid leakage165.4%
Osteolysis124.1%
Failure of implant113.7%
Injurya physical injury82.7%
Impaired healingslow healing62%
Physical asymmetry62%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureUnknown Screw/Rod Construct AccessoriesProduct code MNHAll MAUDE reports
Reports2964,39326,136,888
Share of that pool—6.7%0%
Classified as death, per 1,000 reports009
Classified as injury99%64.2%36.2%
Classified as malfunction1%35%62.3%
Filed by the manufacturer100%99.3%94.9%

Shares are of reports, not 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."

Other brands with product code MNH

BrandReportsLatest 12 monthsClassified as death
Creo427480.2%
Ti Collar With Grooves28600%
Ti Nut 11mm Width Across Flats32800%
Xia 3 Titanium Blocker34070%
Unknown Screws652231.7%
Unknown Mono/Polyaxial Screws39000%
Ti Locking Screw42200%
Unknown Rods18391.1%
Verse Correction Key28830%
Mis Single Inner Setscw20990.5%
Unknown Cage/Spacer28040%
Unknown_Spine_Product596240%
Ti Matrix Locking Cap48901.2%
Cd Horizon Solera 5 5/6 04781310%
UNK - Constructs: Plate/Screws85090%

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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Unknown Screw/Rod Construct Accessories reports

How many FDA reports name Unknown Screw/Rod Construct Accessories?

296 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

injury (99%) and malfunction (1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (3%), migration (2%), corroded (1%), device-device incompatibility (0.3%) and material twisted/bent (0.3%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Unknown Screw/Rod Construct Accessories was at fault?

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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.