MAUDE Adverse Event Report: ISOTIS ORTHOBIOLOGICS INC. SYNPLUG CEMENT RESTRICTOR; CEMENT OBTURATOR

Model Number 804020

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problem Osteolysis (2377)

Event Date 08/16/2023

Event Type  malfunction  

Event Description

On 27 sep 2023, seaspine received information regarding a patient who had previously undergone hip surgery involving the use of synplug.During a follow-up visit conducted approximately 14 years after the surgery, radiography revealed the presence of osteolysis in the left (ref report #3001503333-2023-00002) and right (ref report#3001503333-2023-00003) hip regions where the synplug devices were implanted.

Manufacturer Narrative

The provided radiographs suggest that the biodegradable cement restrictor has undergone degradation.Existing literature indicates the possibility of additional deterioration in the hip prosthesis, potentially leading to a heightened risk of joint fracture.The prosthesis remains in place and no revision surgery has taken place.Osteolysis is evident, but it remains unclear whether this phenomenon is primarily caused by the device or if other physiological factors and interactions play a contributing role.Field safety corrective action (fsca-o-hhe-701) was undertaken to provide safety alert to physicians regarding the possible risk.At or around that time (2014), market withdrawal and destruction of unused product occurred.

• Brand Name: SYNPLUG CEMENT RESTRICTOR
• Type of Device: CEMENT OBTURATOR
• Manufacturer (Section D): ISOTIS ORTHOBIOLOGICS INC.; 2 goodyear, suite a; irvine CA 92618
• Manufacturer (Section G): ISOTIS ORTHOBIOLOGICS INC.; 2 goodyear, suite a; irvine CA 92618
• Manufacturer Contact: audrey mudderman ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 17861901
• MDR Text Key: 324815274
• Report Number: 3001503333-2023-00003
• Device Sequence Number: 1
• Product Code: LZN
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K010840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 804020
• Device Catalogue Number: 804020
• Device Lot Number: 200.155/B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other