Reported Reactions

Devices › Pin, fixation, threaded

Device brand name · Pin fixation threaded

Unkn Taylor Spatial Frame Exfix Dev: medical device reports filed with FDA

175 reports name it, 2020–2024. Manufacturer given most often on reports: Smith & Nephew. Product code JDW.

175
device reports naming the brand
0% of all MAUDE reports · about 28 a year
0
reports, 12 months to August 2026
1 in the 12 months before
0%
classified as malfunction
21.6% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 175 reports that name the brand "Unkn Taylor Spatial Frame Exfix Dev" (pin fixation threaded), received between May 2020 and September 2024; the manufacturer given most often on reports is Smith & Nephew. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, against 1 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 (100%); across all pin, fixation, threaded reports (product code JDW) death is recorded in 0.1% and malfunction in 21.6%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are break (1.1%), compatibility problem (0.6%) and loosening of implant not related to bone-ingrowth (0.6%). The patient problems coded most often are nonunion/delayed-union bone fracture, deformity/ disfigurement and appropriate clinical signs, symptoms and conditions term/code not available. 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

0611Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 2Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 11Sep 2022: 1Oct 2022: 0Nov 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: 7Dec 2023: 32024Jan 2024: 6Feb 2024: 3Mar 2024: 4Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 10Sep 2024: 1Oct 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

045892020: 8920202021: 3820212022: 1420222023: 1020232024: 242024

Event type and report source

Event type, as classified on the report

Death0%0
Injury100%175
Malfunction0%0
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%175
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 2,173 reports carrying product code JDW. 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 broke21.1%19.9%
Compatibility problem10.6%0%
Loosening of implant not related to bone-ingrowth10.6%0.5%
Patient device interaction problem10.6%3.4%

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
Nonunion/delayed-union bone fracture2112%
Deformity/ disfigurement137.4%
Appropriate clinical signs, symptoms and conditions term/code not available74%
Bone fracture(s)63.4%
Malunion of bone63.4%
Painpain, site not specified52.9%
Post operative wound infection42.3%
Bacterial infectiona bacterial infection31.7%
Failure of implant31.7%
Ambulation or postural difficulties21.1%
Arthritis21.1%
Inflammationinflammation21.1%
Injurya physical injury21.1%
Joint contracture21.1%
Necrosisdeath of tissue21.1%

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

In context

MeasureUnkn Taylor Spatial Frame Exfix DevProduct code JDWAll MAUDE reports
Reports1752,17326,136,888
Share of that pool—8.1%0%
Classified as death, per 1,000 reports019
Classified as injury100%77.2%36.2%
Classified as malfunction0%21.6%62.3%
Filed by the manufacturer100%96.8%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 JDW

BrandReportsLatest 12 monthsClassified as death
Unknown Apex Pin38100.5%
UNK Fixation Pin189450%
Apex876781.3%
Tsrh Spinal System45700.4%

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." 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 Unkn Taylor Spatial Frame Exfix Dev reports

How many FDA reports name Unkn Taylor Spatial Frame Exfix Dev?

175 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 (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (1.1%), compatibility problem (0.6%), loosening of implant not related to bone-ingrowth (0.6%) and patient device interaction problem (0.6%). 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 Unkn Taylor Spatial Frame Exfix Dev 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.