PEDIATRIC PATIENT POSITIONER
Received Apr 23, 2025 · Event occurred Mar 24, 2025
Report 2027467-2025-00058 · MDR key 21896118
Device
Generic name
Support, Patient Position
Manufacturer
Alphatec Spine, Inc.Model number
551-200Catalog number
551-200
Lot number
EM56145R
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
NA · Unknown
- Abrasion
- Abrasion
Narrative
Additional Manufacturer Narrative
THE POSITIONER HAS NOT RETURNED FOR EVALUATION. PHOTOGRAPHS WERE NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO MANUFACTURING OR PROCESSING RELATED IRREGULARITIES THAT WOULD CAUSE OR CONTRIBUTE TO THIS EVENT. ALPHATEC SPINE IS SUBMITTING THIS REPORT TO COMPLY WITH THE FDA REGULATIONS 21 CFR 803. ALPHATEC SPINE HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS AVAILABLE. ANY FIELD THAT IS LEFT BLANK WAS NOT KNOWN AT THE TIME OF THIS SUBMISSION. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
FOLLOWING A SURGERY, IT WAS REPORTED THAT THE PATIENT HAD A COUPLE OF MINOR CUTS ON THEIR FOREARM.