BEUDAMED

Tool · Post-Market Surveillance

PSUR Report

The vigilance database section of your PSUR, generated in seconds: FDA MAUDE adverse event trends, recalls, and enforcement classifications for your device and similar devices — with the documented, reproducible methodology auditors ask for.

Reporting period 2024-07 – 2026-06 · FDA data refreshed ~monthly

Sign in to save this report 🔒 Print / export Pro

Product Code: HRS FDA class 2

Plate, Fixation, Bone

View full classification →

Adverse events in period

4,011

0% vs. prior period (4,026)

Deaths reported

10

Recalls in period

37

Class I enforcement

0

Adverse events per month

2024-07 – 2026-06

Loading...

🔒 Download CSV Pro

Events by type

Period vs. prior period

Loading...

Event type

Period

Prior

Death

10

9

Injury

2,978

2,988

Malfunction

1,023

1,029

🔒 Download CSV Pro

Most reported coded problems

Top 15

Product problems

Count

Adverse Event Without Identified Device or Use Problem

1,766

Break

480

Fracture

417

Device-Device Incompatibility

259

Migration

221

Patient Device Interaction Problem

195

Positioning Failure

97

Loosening of Implant Not Related to Bone-Ingrowth

90

Material Twisted/Bent

83

Patient-Device Incompatibility

63

Material Deformation

50

Unintended Movement

47

Device Dislodged or Dislocated

47

Use of Device Problem

44

Defective Device

40

Patient problems

Count

No Clinical Signs, Symptoms or Conditions

789

Insufficient Information

647

Pain

588

Nonunion/Delayed-union Bone Fracture

425

Failure of Implant

375

Unspecified Infection

262

Bone Fracture(s)

147

Skin Inflammation/ Irritation

144

Foreign Body In Patient

109

Post Operative Wound Infection

108

Malunion of Bone

88

Muscle/Tendon Damage

82

Discomfort

71

Loss of Range of Motion

70

Impaired Healing

67

🔒 Download CSV Pro

Recalls in period

37 total

FDA enforcement classification: Class II: 38

Date

Recalling firm

Status

Reason

2026-05-28

Acumed LLC

Open, Classified

Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.

2026-01-23

I.T.S. GmbH Autal 28 Lasnitzhohe Austria

Open, Classified

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

2026-01-23

I.T.S. GmbH Autal 28 Lasnitzhohe Austria

Open, Classified

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

2026-01-23

I.T.S. GmbH Autal 28 Lasnitzhohe Austria

Open, Classified

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

2026-01-23

I.T.S. GmbH Autal 28 Lasnitzhohe Austria

Open, Classified

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

2026-01-23

I.T.S. GmbH Autal 28 Lasnitzhohe Austria

Open, Classified

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

2026-01-23

I.T.S. GmbH Autal 28 Lasnitzhohe Austria

Open, Classified

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

2026-01-23

I.T.S. GmbH Autal 28 Lasnitzhohe Austria

Open, Classified

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

2026-01-23

I.T.S. GmbH Autal 28 Lasnitzhohe Austria

Open, Classified

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

2026-01-23

I.T.S. GmbH Autal 28 Lasnitzhohe Austria

Open, Classified

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

2026-01-23

I.T.S. GmbH Autal 28 Lasnitzhohe Austria

Open, Classified

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

2026-01-23

I.T.S. GmbH Autal 28 Lasnitzhohe Austria

Open, Classified

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

2026-01-23

I.T.S. GmbH Autal 28 Lasnitzhohe Austria

Open, Classified

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

2026-01-23

I.T.S. GmbH Autal 28 Lasnitzhohe Austria

Open, Classified

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

2026-01-23

I.T.S. GmbH Autal 28 Lasnitzhohe Austria

Open, Classified

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

2026-01-23

I.T.S. GmbH Autal 28 Lasnitzhohe Austria

Open, Classified

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

2025-12-19

Tyber Medical

Open, Classified

The supplier manufactured anatomical left plates with an incorrect thread orientation.

2025-12-19

Tyber Medical

Open, Classified

The supplier manufactured anatomical left plates with an incorrect thread orientation.

2025-09-17

CPM Medical Consultants, LLC.

Open, Classified

Instructions for use for a foot plating system is being updated to remove the second option of requirements for sterilization which was 3 minutes exposure time at 134-137-degrees C (273-279-degrees F) and 40mBar for 5-10 minutes drying time, because these requirements do not apply in the United States.

2025-01-21

Tyber Medical

Open, Classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

2025-01-21

Tyber Medical

Open, Classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

2025-01-21

Tyber Medical

Open, Classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

2025-01-21

Tyber Medical

Open, Classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

2025-01-21

Tyber Medical

Open, Classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

2025-01-21

Tyber Medical

Open, Classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

2025-01-21

Tyber Medical

Open, Classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

2025-01-21

Tyber Medical

Open, Classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

2025-01-21

Tyber Medical

Open, Classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

2025-01-21

Tyber Medical

Open, Classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

2025-01-21

Tyber Medical

Open, Classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

2025-01-21

Tyber Medical

Open, Classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

2025-01-21

Tyber Medical

Open, Classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

2025-01-21

Tyber Medical

Open, Classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

2025-01-21

Tyber Medical

Open, Classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

2025-01-21

Tyber Medical

Open, Classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

2025-01-21

Tyber Medical

Open, Classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

2025-01-21

Tyber Medical

Open, Classified

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

🔒 Download CSV Pro

Adverse events by year

Loading...

🔒 Download CSV Pro

Methodology & data provenance

For your PSUR appendix

Search protocol: FDA MAUDE adverse event reports, FDA device recalls, and FDA enforcement reports (openFDA datasets) were queried for product code HRS, reporting period 2024-07 to 2026-06 (prior comparison period 2022-07 to 2024-06).

Data coverage: adverse event data for these product codes extends through 2026-05. Source openFDA export dated 2026-06-30. Recall records with missing or implausible initiation dates (0 for these codes) are excluded from period counts.

Generated: 2026-07-05 21:00 UTC by BEUDAMED (beudamed.com/fda/psur-report). Dataset sizes: 25,039,198 adverse events, 58,607 recalls, 39,365 enforcement reports.

🔒 Download summary CSV Pro

PSUR database searches, explained

Under the EU MDR, manufacturers must produce a Periodic Safety Update Report (PSUR) (Class IIa and above; a PMS report for Class I) on a defined schedule. A required part of that report is a survey of publicly available vigilance data — most importantly the FDA's MAUDE adverse event database and FDA recall records — covering both your own device and similar devices on the market (the "state of the art").

Doing this by hand means repeated MAUDE queries, manual export, deduplication, and trending — hours of work per report, repeated every reporting period. This tool runs the same search protocol in seconds and documents it: which datasets were queried, with which filters, when, and with what coverage — so the search is reproducible, which is exactly what a Notified Body auditor wants to see.

Event counts are grouped by the FDA's reported event type (death, injury, malfunction). Name-based device matching is clearly labeled as indicative: only you can confirm whether a specific MAUDE report concerns your device. Recall records with implausible dates are excluded and the exclusion is disclosed. All data is from the official openFDA datasets and refreshed approximately monthly.