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Device brand name · Orthopedic manual surgical instrument
Orthopedic Manual Surgical Instrument: medical device reports filed with FDA
1,143 reports name it, 2010–2020. Manufacturer given most often on reports: Medtronic Sofamor Danek USA. Product code LXH.
- 1,143
- device reports naming the brand
- 0% of all MAUDE reports · about 71 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 85.9%
- classified as malfunction
- 90.1% across the product code
- 0.2%
- classified as death, as reported
- 2 reports · not verified by FDA
1,143 medical device reports received by FDA name the brand "Orthopedic Manual Surgical Instrument" (orthopedic manual surgical instrument); the manufacturer given most often on reports is Medtronic Sofamor Danek USA; received from May 2010 to October 2020. 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 (85.9%), injury (12.1%) and death (0.2%); 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 (74%), mechanical problem (5.8%) and loose or intermittent connection (3.1%). The patient problems coded most often are device embedded in tissue or plaque, injury and blood loss. 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 Orthopedic Manual Surgical Instrument was received in the five years to August 2026; the latest was received in October 2020.
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 | 846 | 74% | 43.5% |
| Mechanical problema mechanical problem | 66 | 5.8% | 1.5% |
| Loose or intermittent connection | 35 | 3.1% | 0.6% |
| Detachment of device component | 27 | 2.4% | 2.7% |
| Material deformation | 17 | 1.5% | 3.9% |
| Device inoperablethe device could not be used | 12 | 1% | 0.2% |
| Mechanical jam | 12 | 1% | 2.2% |
| Component missing | 11 | 1% | 1% |
| Crackthe device cracked | 11 | 1% | 3.2% |
| Device slipped | 10 | 0.9% | 0.8% |
| Difficult to removethe device was hard to remove | 9 | 0.8% | 1.3% |
| Material twisted/bent | 8 | 0.7% | 2.3% |
| Disassembly | 6 | 0.5% | 0.3% |
| Fracturea broken bone | 6 | 0.5% | 8.5% |
| Bent | 5 | 0.4% | 0.9% |
| Intermittent continuity | 5 | 0.4% | 0% |
| Detachment of device or device componentpart of the device came off | 4 | 0.3% | 2.5% |
| Difficult to insertthe device was hard to insert | 4 | 0.3% | 0.6% |
| Difficult to position | 4 | 0.3% | 0.1% |
| Failure to align | 4 | 0.3% | 0.7% |
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 | 107 | 9.4% |
| Injurya physical injury | 11 | 1% |
| Blood loss | 10 | 0.9% |
| Bone fracture(s) | 5 | 0.4% |
| Perforation of vessels | 5 | 0.4% |
| Foreign body in patientpart of a device left in the patient | 4 | 0.3% |
| Discomfortdiscomfort | 3 | 0.3% |
| Laceration(s) | 3 | 0.3% |
| Painpain, site not specified | 3 | 0.3% |
| Cerebrospinal fluid leakage | 2 | 0.2% |
| No patient involvement | 2 | 0.2% |
| Spinal column injury | 2 | 0.2% |
| Abdominal cramps | 1 | 0.1% |
| Abdominal painstomach or belly pain | 1 | 0.1% |
| Abscessa collection of pus | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Orthopedic Manual Surgical Instrument | Product code LXH | All MAUDE reports |
|---|---|---|---|
| Reports | 1,143 | 81,663 | 26,136,888 |
| Share of that pool | — | 1.4% | 0% |
| Classified as death, per 1,000 reports | 2 | 1 | 9 |
| Classified as injury | 12.1% | 9.2% | 36.2% |
| Classified as malfunction | 85.9% | 90.1% | 62.3% |
| Filed by the manufacturer | 99.8% | 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% |
| Manual Orthopedic Surgical Instrument | 1,693 | 0 | 0.1% |
| 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 Orthopedic Manual Surgical Instrument reports
How many FDA reports name Orthopedic Manual Surgical Instrument?
1,143 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 (85.9%), injury (12.1%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (74%), mechanical problem (5.8%), loose or intermittent connection (3.1%), detachment of device component (2.4%) and material deformation (1.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Orthopedic Manual 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.