Prosthesis, penile: medical device reports filed with FDA

2,776 reports carry this product code, 1992–2026; 15 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

2,776
reports with this product code: 0% of all MAUDE reports; 199
reports, 12 months to August 2026: 200 in the 12 months before; 8.5%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code FAE is FDA's classification for "Prosthesis, penile" (gastroenterology, Urology panel), a class 2 device. 2,776 medical device reports carry this product code, 0% of the MAUDE database, from March 1992 to August 2026.

199 reports arrived in the 12 months to August 2026, close to the 200 of 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 (90.7%), malfunction (8.5%) and other (0.4%). 15 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
AMS Spectra Concealable Penile Prosthesis	953	10	0.1%	4.4%
Tactra Malleable Penile Prothesis	454	51	0%	4.6%
Malleable Penile Prosthesis	284	0	0%	0.7%
Spectra	39	8	3%	12.2%
AMS Inflatable Penile Prosthesis	23	687	0%	7.5%
Inflatable Penile Prosthesis	23	8	0%	0.7%
Titan	10	0	0%	23.8%
Alpha I	8	0	0%	0.7%
AMS Ambicor Penile Prosthesis	6	28	0%	10.5%
Genesis	6	0	0.1%	1.9%
Ambicor Penile Prosthesis	3	0	0%	0.6%
Surgitek	3	0	1.3%	14.3%
Hydroflex Penile Prosthesis	1	0	0%	0.6%
Mentor	1	0	0.1%	30.1%
Titan Touch Scro Zero Ang 22cm	1	0	0%	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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
American Medical Systems	662	23.8%
Coloplast A/S	361	13%
American Medical Systems Mn	282	10.2%
Mentor	23	0.8%
Mentor - Minnesota Division	11	0.4%
Medical Engineering	8	0.3%

Reports by month, five years

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

Event type and report source

Event type

Death0%1

Injury90.7%2,518

Malfunction8.5%236

Other0.4%12

Not given0.3%9

Who filed

Manufacturer report91%2,527

Voluntary report1.9%52

User facility report0%0

Distributor report0.2%6

Not given6.9%191

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Insufficient device problem information	860	31%
Inadequacy of device shape and/or size	152	5.5%
Mechanical problema mechanical problem	141	5.1%
Defective devicethe device was defective	94	3.4%
Migrationthe device moved from where it was placed	81	2.9%
Explanted	74	2.7%
Device operates differently than expectedthe device behaved unexpectedly	66	2.4%
Fracturea broken bone	52	1.9%
Malposition of device	48	1.7%
Breakthe device broke	42	1.5%
Migration or expulsion of device	36	1.3%
Extrusion	31	1.1%
Material erosion	30	1.1%
Inflation problem	29	1%
Device inoperablethe device could not be used	19	0.7%
Leak/splashthe device leaked	18	0.6%
Fluid/blood leak	15	0.5%
Material puncture/hole	14	0.5%
Nonstandard device	14	0.5%
Replace	14	0.5%

Questions about prosthesis, penile reports

What is product code FAE?

FDA's classification code for "Prosthesis, penile", class 2, reviewed by the gastroenterology, Urology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,776 reports through August 2026, 199 of them in the latest 12 months.

Which brands appear most often?

AMS Spectra Concealable Penile Prosthesis (953), Tactra Malleable Penile Prothesis (454), Malleable Penile Prosthesis (284), Spectra (39) and AMS Inflatable Penile Prosthesis (23). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.