Devices › Prosthesis, shoulder, hemi-, humeral, metallic uncemented
Device brand name · Delta xtend implants screws
Dxtend Screw Lock D4 5x36mm: medical device reports filed with FDA
245 reports name it, 2007–2026. Manufacturer given most often on reports: Depuy France Sas - 3003895575. Product code HSD.
- 245
- device reports naming the brand
- 0% of all MAUDE reports · about 13 a year
- 11
- reports, 12 months to August 2026
- 15 in the 12 months before
- 33.1%
- classified as malfunction
- 15.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 245 reports that name the brand "Dxtend Screw Lock D4 5x36mm" (delta xtend implants screws), received between August 2007 and March 2026; the manufacturer given most often on reports is Depuy France Sas - 3003895575. Spellings of one product vary from report to report.
11 reports arrived in the 12 months to August 2026, down 27% from 15 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 (66.9%) and malfunction (33.1%); across all prosthesis, shoulder, hemi-, humeral, metallic uncemented reports (product code HSD) death is recorded in 0.3% and malfunction in 15.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are fracture (23.7%), break (7.8%) and osseointegration problem (7.3%). The patient problems coded most often are pain, inadequate osseointegration 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
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
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 10,267 reports carrying product code HSD. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Fracturea broken bone | 58 | 23.7% | 5.5% |
| Breakthe device broke | 19 | 7.8% | 4.2% |
| Osseointegration problem | 18 | 7.3% | 2.6% |
| Insufficient device problem information | 17 | 6.9% | 13.2% |
| Loss of osseointegration | 14 | 5.7% | 2.9% |
| Difficult to advance | 4 | 1.6% | 0% |
| Difficult to insertthe device was hard to insert | 2 | 0.8% | 1.8% |
| Loose or intermittent connection | 2 | 0.8% | 1.7% |
| Manufacturing, packaging or shipping problem | 2 | 0.8% | 0.1% |
| Material deformation | 2 | 0.8% | 0.3% |
| Off-label use | 2 | 0.8% | 0.1% |
| Difficult to removethe device was hard to remove | 1 | 0.4% | 0.3% |
| Failure to advance | 1 | 0.4% | 0.1% |
| Inadequacy of device shape and/or size | 1 | 0.4% | 0.6% |
| Mechanical problema mechanical problem | 1 | 0.4% | 0.1% |
| Metal shedding debris | 1 | 0.4% | 0.1% |
| Migrationthe device moved from where it was placed | 1 | 0.4% | 0.7% |
| Nonstandard device | 1 | 0.4% | 0.3% |
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) | Reports | Share |
|---|---|---|
| Painpain, site not specified | 32 | 13.1% |
| Inadequate osseointegration | 26 | 10.6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 12 | 4.9% |
| Not applicable | 11 | 4.5% |
| Joint laxity | 8 | 3.3% |
| Bone fracture(s) | 7 | 2.9% |
| Discomfortdiscomfort | 5 | 2% |
| Falla fall | 5 | 2% |
| Foreign body reaction | 5 | 2% |
| Loss of range of motion | 4 | 1.6% |
| Pneumonialung infection | 3 | 1.2% |
| Foreign body in patientpart of a device left in the patient | 2 | 0.8% |
| Limited mobility of the implanted joint | 2 | 0.8% |
| Osteolysis | 2 | 0.8% |
| Device embedded in tissue or plaque | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Dxtend Screw Lock D4 5x36mm | Product code HSD | All MAUDE reports |
|---|---|---|---|
| Reports | 245 | 10,267 | 26,136,888 |
| Share of that pool | — | 2.4% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 66.9% | 81.6% | 36.2% |
| Classified as malfunction | 33.1% | 15.3% | 62.3% |
| Filed by the manufacturer | 100% | 98.8% | 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 HSD
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Dxtend Metaglene | 355 | 14 | 0% |
| Dxtend Glenosphere Std D38mm | 323 | 5 | 0% |
| Unknown Shoulder Metaglene | 305 | 16 | 0.3% |
| Dxtend Stand Pe Cup D38 +3mm | 307 | 8 | 0% |
| Flexible Shaft W/Cir Connector | 152 | 12 | 0% |
| Dxtend Screw No Lock D4 5x18mm | 199 | 21 | 0% |
| Unknown Shoulder Implant | 254 | 8 | 0.8% |
| Dxtend Glenosphere Std D42mm | 227 | 3 | 0% |
| Unknown Shoulder Humeral Stems | 239 | 8 | 1.7% |
| Dxtend Screw Lock D4 5x30mm | 192 | 12 | 0% |
| Dxtend Glenosphere Ecc D42mm | 164 | 0 | 0% |
| Dxtend Stand Pe Cup D38 +6mm | 196 | 2 | 0% |
| Dxtend Stand Pe Cup D38 +9mm | 162 | 5 | 0% |
| Unknown Shoulder Glenosphere | 335 | 24 | 0.3% |
| Delta Xtend | 208 | 205 | 0% |
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 Dxtend Screw Lock D4 5x36mm reports
How many FDA reports name Dxtend Screw Lock D4 5x36mm?
245 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 11 in the latest 12 months.
What kinds of events are reported?
injury (66.9%) and malfunction (33.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fracture (23.7%), break (7.8%), osseointegration problem (7.3%), insufficient device problem information (6.9%) and loss of osseointegration (5.7%). 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 Dxtend Screw Lock D4 5x36mm 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.