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Device brand name · Orthopedic manual surgical instrument
Manual Orthopedic Surgical Instrument: medical device reports filed with FDA
1,693 reports name it, 2006–2018. Manufacturer given most often on reports: Medtronic Sofamor Danek. Product code LXH.
- 1,693
- device reports naming the brand
- 0% of all MAUDE reports · about 85 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 88%
- classified as malfunction
- 90.1% across the product code
- 0.1%
- classified as death, as reported
- 1 reports · not verified by FDA
1,693 medical device reports received by FDA name the brand "Manual Orthopedic Surgical Instrument" (orthopedic manual surgical instrument); the manufacturer given most often on reports is Medtronic Sofamor Danek; received from September 2006 to October 2018. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (88%), injury (6.9%) and other (2.2%); across all orthopedic manual surgical instrument reports (product code LXH) death is recorded in 0.1% and malfunction in 90.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (84.2%), device, or device fragments remain in patient (4.1%) and tip breakage (3.2%). The patient problems coded most often are device embedded in tissue or plaque, foreign body, removal of and nonresorbable materials, unretrieved in body. 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
No report naming Manual Orthopedic Surgical Instrument was received in the five years to August 2026; the latest was received in October 2018.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 81,663 reports carrying product code LXH. 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 |
|---|---|---|---|
| Breakthe device broke | 1,426 | 84.2% | 43.5% |
| Device, or device fragments remain in patient | 69 | 4.1% | 0.7% |
| Tip breakage | 54 | 3.2% | 1.1% |
| Device, removal of (non-implant) | 27 | 1.6% | 0.2% |
| Detachment of device component | 26 | 1.5% | 2.7% |
| Crackthe device cracked | 22 | 1.3% | 3.2% |
| Malfunction | 14 | 0.8% | 0.4% |
| Naturally worn | 13 | 0.8% | 2.4% |
| Bent | 11 | 0.6% | 0.9% |
| Device slipped | 11 | 0.6% | 0.8% |
| Difficult to insertthe device was hard to insert | 11 | 0.6% | 0.6% |
| Fracturea broken bone | 10 | 0.6% | 8.5% |
| Device inoperablethe device could not be used | 9 | 0.5% | 0.2% |
| Material frayed | 9 | 0.5% | 0% |
| Device contamination with chemical or other material | 6 | 0.4% | 0.3% |
| Device damaged by another device | 6 | 0.4% | 0.1% |
| Insufficient device problem information | 5 | 0.3% | 1.1% |
| Loose or intermittent connection | 5 | 0.3% | 0.6% |
| Sticking | 5 | 0.3% | 0.8% |
| Component falling | 4 | 0.2% | 0.5% |
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 |
|---|---|---|
| Device embedded in tissue or plaque | 141 | 8.3% |
| Foreign body, removal of | 56 | 3.3% |
| Nonresorbable materials, unretrieved in body | 34 | 2% |
| Painpain, site not specified | 13 | 0.8% |
| Surgical procedure, additional | 13 | 0.8% |
| Dural tear | 8 | 0.5% |
| Visual disturbances | 7 | 0.4% |
| Surgery, prolonged | 6 | 0.4% |
| Nonspecific | 5 | 0.3% |
| Blood loss | 4 | 0.2% |
| Bone fracture(s) | 4 | 0.2% |
| Foreign body in patientpart of a device left in the patient | 4 | 0.2% |
| Injurya physical injury | 4 | 0.2% |
| Neurological deficit/dysfunction | 4 | 0.2% |
| Not applicable | 4 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Manual Orthopedic Surgical Instrument | Product code LXH | All MAUDE reports |
|---|---|---|---|
| Reports | 1,693 | 81,663 | 26,136,888 |
| Share of that pool | — | 2.1% | 0% |
| Classified as death, per 1,000 reports | 1 | 1 | 9 |
| Classified as injury | 6.9% | 9.2% | 36.2% |
| Classified as malfunction | 88% | 90.1% | 62.3% |
| Filed by the manufacturer | 99.9% | 98.6% | 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 LXH
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Excel T-Handle | 2,368 | 150 | 0% |
| Driving Cap/Threaded | 1,181 | 58 | 0% |
| Orthopedic Manual Surgical Instrument | 1,143 | 0 | 0.2% |
| METRx System | 1,679 | 267 | 0.1% |
| Glenosphere Inserter Tip | 812 | 175 | 0% |
| Baseplate Inserter Rod | 561 | 105 | 0% |
| 1.5mm Hex Driver Tip, Locking Groove | 580 | 332 | 0% |
| R3 Straight Shell Impactor | 565 | 21 | 0% |
| Driving Cap | 497 | 65 | 0% |
| 5mm Hex Flexible Screwdriver | 498 | 60 | 0.2% |
| Attune Mod Post Saw Cap Sz 6-8 | 486 | 41 | 0% |
| Exactech | 576 | 0 | 0% |
| Attune Femoral Impactor | 3,328 | 121 | 0% |
| Metrx | 415 | 3 | 0% |
| Cor/Tri Ant Stem Insert Shaft | 1,207 | 50 | 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 Manual Orthopedic Surgical Instrument reports
How many FDA reports name Manual Orthopedic Surgical Instrument?
1,693 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?
malfunction (88%), injury (6.9%) and other (2.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (84.2%), device, or device fragments remain in patient (4.1%), tip breakage (3.2%), device, removal of (non-implant) (1.6%) and detachment of device component (1.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Manual Orthopedic Surgical Instrument 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.