Reported Reactions

Devices › Drills, burrs, trephines & accessories (compound, powered)

Device brand name · Disposable perforators

Codman Dispos Perforator: medical device reports filed with FDA

676 reports name it, 1999–2026. Manufacturer given most often on reports: Raynham. Product code HBF.

676
device reports naming the brand
0% of all MAUDE reports · about 25 a year
21
reports, 12 months to August 2026
38 in the 12 months before
53.7%
classified as malfunction
48.6% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 676 reports that name the brand "Codman Dispos Perforator" (disposable perforators), received between January 1999 and July 2026; the manufacturer given most often on reports is Raynham. Spellings of one product vary from report to report.

21 reports arrived in the 12 months to August 2026, down 45% from 38 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 malfunction (53.7%), injury (45.9%) and other (0.4%); across all drills, burrs, trephines & accessories (compound, powered) reports (product code HBF) death is recorded in 0.1% and malfunction in 48.6%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are fail-safe did not operate (27.7%), activation, positioning or separation problem (21.9%) and failure to auto stop (13.9%). The patient problems coded most often are brain injury, injury and tissue damage. 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

0815Sep 2021: 13Oct 2021: 5Nov 2021: 8Dec 2021: 82022Jan 2022: 3Feb 2022: 6Mar 2022: 12Apr 2022: 0May 2022: 11Jun 2022: 5Jul 2022: 9Aug 2022: 3Sep 2022: 5Oct 2022: 7Nov 2022: 6Dec 2022: 22023Jan 2023: 3Feb 2023: 2Mar 2023: 4Apr 2023: 4May 2023: 7Jun 2023: 14Jul 2023: 6Aug 2023: 9Sep 2023: 1Oct 2023: 4Nov 2023: 2Dec 2023: 32024Jan 2024: 15Feb 2024: 14Mar 2024: 11Apr 2024: 10May 2024: 7Jun 2024: 15Jul 2024: 6Aug 2024: 6Sep 2024: 8Oct 2024: 6Nov 2024: 4Dec 2024: 22025Jan 2025: 4Feb 2025: 1Mar 2025: 1Apr 2025: 2May 2025: 1Jun 2025: 3Jul 2025: 3Aug 2025: 3Sep 2025: 3Oct 2025: 4Nov 2025: 0Dec 2025: 02026Jan 2026: 2Feb 2026: 2Mar 2026: 3Apr 2026: 1May 2026: 2Jun 2026: 2Jul 2026: 2Aug 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

0711421999: 719992006: 82007: 320072008: 92009: 520092010: 52019: 8620192020: 1422021: 14020212022: 692023: 5920232024: 1042025: 2520252026: 14

Event type and report source

Event type, as classified on the report

Death0%0
Injury45.9%310
Malfunction53.7%363
Other0.4%3
Not given0%0

Who filed the report

Manufacturer report99.7%674
Voluntary report0.1%1
User facility report0%0
Distributor report0%0
Not given0.1%1

Grey bar: all 2,732 reports carrying product code HBF. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Fail-safe did not operate18727.7%7.6%
Activation, positioning or separation problem14821.9%6.1%
Failure to auto stop9413.9%23.8%
Mechanical problema mechanical problem527.7%2.8%
Breakthe device broke446.5%4.5%
Material separation385.6%2%
Dull, blunt152.2%3%
Activation problem50.7%0.2%
Insufficient device problem information50.7%1.2%
Premature indicator activation50.7%0.2%
Entrapment of device40.6%0.7%
Material integrity problema problem with the device material40.6%0%
Positioning problem40.6%0.1%
Defective devicethe device was defective30.4%0.2%
Separation problem30.4%0.1%
Difficult to removethe device was hard to remove20.3%1.4%
Excessive heating20.3%0.1%
Failure to cut20.3%0.4%
Failure to eject20.3%0.1%
Flaked20.3%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
Brain injury11517%
Injurya physical injury8813%
Tissue damage304.4%
Hemorrhage/blood loss/bleeding91.3%
Contusiona bruise81.2%
Laceration(s)50.7%
No patient involvement50.7%
Appropriate clinical signs, symptoms and conditions term/code not available40.6%
Perforation40.6%
Intracranial hemorrhage20.3%
Altered state of consciousness10.1%
Bruise/contusion10.1%
Burn(s)a burn10.1%
Convulsion/seizure10.1%
Dysphasia10.1%

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

In context

MeasureCodman Dispos PerforatorProduct code HBFAll MAUDE reports
Reports6762,73226,136,888
Share of that pool—24.7%0%
Classified as death, per 1,000 reports019
Classified as injury45.9%49.5%36.2%
Classified as malfunction53.7%48.6%62.3%
Filed by the manufacturer99.7%90.8%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 HBF

BrandReportsLatest 12 monthsClassified as death
Codman Disposable Perforator64700.2%
Easydrill Perforator417370%
Codman18301.6%
Mayfield18930%
Mayfield Modified Skull Clamp2,663750%
Midas Rex6885910%
Perforator Driver W/Hudson End69500%
Drill Bit158250%
Hakim Programmable Valve69390.9%
Midas Rex Legend9523560%
Motor Mr8 Electric32540%

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 Codman Dispos Perforator reports

How many FDA reports name Codman Dispos Perforator?

676 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 21 in the latest 12 months.

What kinds of events are reported?

malfunction (53.7%), injury (45.9%) and other (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

fail-safe did not operate (27.7%), activation, positioning or separation problem (21.9%), failure to auto stop (13.9%), mechanical problem (7.7%) and break (6.5%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.7%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Codman Dispos Perforator 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.