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

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

Patient Problem Osteolysis (2377)

Event Date 07/31/2023

Event Type  malfunction  

Event Description

On 27 sep 2023, seaspine received information regarding a patient who had previously undergone knee surgery involving the use of synplug.During a follow-up visit, radiography revealed the presence of osteolysis and a fatigue fracture in the right tibia.

Manufacturer Narrative

Surgery was performed on (b)(6) 2023, involving several procedures: osteosynthesis/protective osteosynthesis of the right tibia using a long ncb tibia plate.Osteotomy/fenestration of the right tibia at the level of palacos cement and the synplug osteolysis.Cement removal from the marrow space of the right tibia.Curettage and removal of the synplug cement block osteolysis in the right tibia.Fascial splitting of the fascia of the musculus tibialis anterior.Removal of bone spongiosa from the left iliac crest.Spongiosa plastic surgery on the right tibia using spongiosa from the left iliac crest.Osteolysis and tibia fracture are evident, however the failures cannot be attributed to the device.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: 17862011
• MDR Text Key: 324818576
• Report Number: 3001503333-2023-00004
• 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
• 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