Reported Reactions

Devices › Implant, endosseous, root-form

Device brand name · Endosseous dental implant

NobRpl Tapered Groovy WP 5x11.5mm: medical device reports filed with FDA

2,737 reports name it, 2019–2026. Manufacturer given most often on reports: Nobel Biocare. Product code DZE.

2,737
device reports naming the brand
0% of all MAUDE reports · about 401 a year
238
reports, 12 months to August 2026
170 in the 12 months before
0.2%
classified as malfunction
0.8% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 2,737 reports that name the brand "NobRpl Tapered Groovy WP 5x11.5mm" (endosseous dental implant), received between September 2019 and August 2026; the manufacturer given most often on reports is Nobel Biocare. Spellings of one product vary from report to report.

238 reports arrived in the 12 months to August 2026, up 40% from 170 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 (99.8%) and malfunction (0.2%); across all implant, endosseous, root-form reports (product code DZE) death is recorded in 0% and malfunction in 0.8%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are failure to osseointegrate (58.6%), loss of osseointegration (36.5%) and osseointegration problem (3.6%). The patient problems coded most often are failure of implant, pain and numbness. 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

0103205Sep 2021: 67Oct 2021: 26Nov 2021: 37Dec 2021: 472022Jan 2022: 37Feb 2022: 39Mar 2022: 49Apr 2022: 25May 2022: 20Jun 2022: 30Jul 2022: 80Aug 2022: 50Sep 2022: 66Oct 2022: 76Nov 2022: 65Dec 2022: 862023Jan 2023: 9Feb 2023: 21Mar 2023: 91Apr 2023: 59May 2023: 39Jun 2023: 205Jul 2023: 24Aug 2023: 57Sep 2023: 12Oct 2023: 11Nov 2023: 19Dec 2023: 452024Jan 2024: 12Feb 2024: 39Mar 2024: 28Apr 2024: 35May 2024: 24Jun 2024: 15Jul 2024: 40Aug 2024: 34Sep 2024: 25Oct 2024: 11Nov 2024: 6Dec 2024: 142025Jan 2025: 12Feb 2025: 14Mar 2025: 22Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 48Aug 2025: 18Sep 2025: 20Oct 2025: 40Nov 2025: 40Dec 2025: 202026Jan 2026: 24Feb 2026: 8Mar 2026: 8Apr 2026: 18May 2026: 8Jun 2026: 14Jul 2026: 25Aug 2026: 13

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

03126232019: 15520192020: 24920202021: 48320212022: 62320222023: 59220232024: 28320242025: 23420252026: 1182026

Event type and report source

Event type, as classified on the report

Death0%0
Injury99.8%2,731
Malfunction0.2%6
Other0%0
Not given0%0

Who filed the report

Manufacturer report59.3%1,623
Voluntary report0%0
User facility report0%0
Distributor report40.7%1,114
Not given0%0

Grey bar: all 3,924,241 reports carrying product code DZE. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Failure to osseointegrate1,60358.6%62.8%
Loss of osseointegration99936.5%22.4%
Osseointegration problem993.6%7.7%
Fracturea broken bone170.6%1.6%
Migrationthe device moved from where it was placed40.1%0.1%
Separation failure30.1%0.1%
Insufficient device problem information20.1%0.2%
Premature separation10%0.1%

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
Failure of implant2,43188.8%
Painpain, site not specified2519.2%
Numbnessnumbness441.6%
Appropriate clinical signs, symptoms and conditions term/code not available120.4%
Abscessa collection of pus80.3%
Implant pain40.1%
Inflammationinflammation40.1%
Hypersensitivity/allergic reaction10%
Sinus perforation10%

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

In context

MeasureNobRpl Tapered Groovy WP 5x11.5mmProduct code DZEAll MAUDE reports
Reports2,7373,924,24126,136,888
Share of that pool—0.1%0%
Classified as death, per 1,000 reports009
Classified as injury99.8%99.2%36.2%
Classified as malfunction0.2%0.8%62.3%
Filed by the manufacturer59.3%77.7%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 DZE

BrandReportsLatest 12 monthsClassified as death
Biohorizons Dental Implant58,73200%
BioHorizons Inc.57,02025,5360%
NobelActive Internal RP 4.3x10mm49,0989,5280%
BLT ?4.1mm RC, SLA? 10mm, TiZr, Loxim45,6509,6770%
NobelParallel CC RP 4.3x10mm44,2699,3180%
BLT ?4.1mm RC, SLActive? 10mm, TiZr, NTP41,6727,5310%
Unknown Implant39,9671,4540%
NobelReplace CC RP 4.3x10mm35,9468,1660%
NobelReplace CC PMC RP 4.3x10mm34,4478,6900%
NobelActive Internal RP 4.3x11.5mm33,1175,7040%
BLT ?3.3mm NC, SLA? 10mm, TiZr, Loxim28,6485,6950%
BLT ?4.1mm RC, SLA? 10mm, Ti, Loxim26,7248,4810%
BLT ?3.3mm NC, SLActive? 10mm, TiZr, NTP26,5404,6800%
NobelActive Internal RP 4.3x13mm25,5563,7640%
BLT ?4.1mm RC, SLA? 8mm, TiZr, Loxim24,7725,9780%

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 NobRpl Tapered Groovy WP 5x11.5mm reports

How many FDA reports name NobRpl Tapered Groovy WP 5x11.5mm?

2,737 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 238 in the latest 12 months.

What kinds of events are reported?

injury (99.8%) and malfunction (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

failure to osseointegrate (58.6%), loss of osseointegration (36.5%), osseointegration problem (3.6%), fracture (0.6%) and migration (0.1%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (59.3%) and distributor reports (40.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that NobRpl Tapered Groovy WP 5x11.5mm 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.