BIOMET SPINALPAK / ORTHOPAK
Received Jul 21, 2026
Report 0002242816-2026-00089 · MDR key 25888969
Device
Product problems
- Patient-Device Incompatibility
Patient
NA · Female
- Rash
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION CAN BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED A RASH ON THE BACK OF THE NECK. THE PATIENT HAD RED WELTS AND ITCHINESS. THE RASH STARTED IN NOVEMBER OF 2025. THE PATIENT HAS NOT USED THE DEVICE SINCE THEN. THE PATIENT DISCUSSED THE ISSUE WITH THE PRESCRIBING SURGEON, AND THEY WERE UNSURE WHETHER THE RASH WAS FROM THE COVER PATCHES. THE PATIENT WAS PRESCRIBED TRIAMCINOLONE 5% AND 1%. THE PATIENT WAS ALSO TAKING A PILL BUT COULD NOT REMEMBER THE NAME. THE PATIENT¿S DOCTOR ADVISED THEM TO DISCONTINUE TREATMENT. NO FURTHER CONSEQUENCES WERE REPORTED.