SILKTOE
Received Aug 31, 2023 · Event occurred Jul 26, 2023
Report 3016669046-2023-00001 · MDR key 17659959
Device
Generic name
Toe Joint Polymer Constrained Prosthesis
Manufacturer
Brm Extremities SrlCatalog number
BRDNEWP3030L
Lot number
0825/22
Product problems
- Fracture
- Fracture
Patient
Unknown
- Failure of Implant
- Failure of Implant
Narrative
Description of Event or Problem
IT WAS REPORTED THAT HE STEM OF A SILICONE SPACER FOR MTP1 REPLACEMENT BRAKE OFF AFTER TWO MONTHS WITHOUT TRAUMA.
Additional Manufacturer Narrative
THE DEVICE BATCH WAS RELEASED ON 25/07/2022 AND CONSISTED OF (B)(4) PIECES, WHICH WERE ENTIRELY SOLD. DHR REVIEW REVEALED NO ANOMALIES, THE PRODUCT COMPLIES WITH THE COMPANY'S REQUIREMENTS. NO FURTHER REPORTS WERE RECEIVED ON THIS BATCH, WHILE ONLY ONE OTHER CASE OF DEVICE FRACTURE WAS REPORTED DURING THE ENTIRE PERIOD OF MARKETING OF THIS DEVICE (RELATING TO A DIFFERENT BATCH). DEVICE FRACTURE IS A RESIDUAL RISK REPORTED IN IFUS. IT COULD BE DUE TO DIFFERENT FACTORS; WE CONTACTED THE DISTRIBUTOR ASKING FOR MORE INFORMATION ON EVENT AND PATIENT AND ARE WAITING FOR AN ANSWER.