NEURO SPNG-1/2X3"-STRL- 20/CS
Received Jun 8, 2026 · Event occurred May 29, 2026
Report 1060680-2026-00009 · MDR key 25429917
Device
Generic name
Gauze/sponge, Internal
Manufacturer
Medsorb Dominicana, S.a.Model number
30-057Lot number
25103463
Product problems
- Material Fragmentation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A USER FACILITY REPORTED, "THE STRING BROKE OFF IN THE PATIENT AND HAD TO BE REMOVED BY THE SURGEON." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, BUT IT HAS NOT YET BEEN RECEIVED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SUPPLIER, (B)(4). THE INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
A USER FACILITY REPORTED, "THE STRING BROKE OFF IN THE PATIENT AND HAD TO BE REMOVED BY THE SURGEON."