MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION SYNPLUG CEMENT RESTRICTOR; CEMENT OBTURATOR

Model Number 804020

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Osteolysis (2377)

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

The product has been absorbed, and therefore no samples can be provided for testing or analysis.The patient will continue to be monitored by their healthcare provider for any indications which would necessitate intervention.Risk management files for the product have been updated to include the originally unidentified risk regarding the occurrence of osteolysis in some patients implanted with the biodegradable cement restrictors.Additionally, a risk benefit analysis was completed in may 2014 that concluded the overall medical benefits of the synplug products may not outweigh individual residual risk of osteolysis, primarily due to the lack of osteolysis reports for other cement restrictor types and options available to surgeon.Based on all available data at that time, no causal relationship between the use of the products and the reported instances of osteolysis could be demonstrated.To date, there are no conclusive findings from similar complaint investigations, or from technical or clinical information in the literature that proves or disproves a causal relationship between synplug & optiplug biodegradable cement restrictors or the materials they are manufactured with, and periprosthetic osteolysis (or fractures as a result).There is no data or findings that would suggest that only some subset of all the products manufactured might be affected.A risk/benefit analysis of two reported fractures, 57 reported osteolysis without the need for medical intervention and (b)(6) patients benefiting from a successful surgery it can be concluded that the benefit outweighs the risk.The finding of osteolysis surrounding the distal cement restrictor is unexpected, and undesirable; however, periprosthetic osteolysis in total hip arthroplasty is a well-known problem that is typically a multifactorial process and may be identified through routine radiographic follow-up.

Event Description

The patient underwent hip replacement surgery in (b)(6) 2006.In a 15-year postoperative follow up appointment on (b)(6) 2021, osteolysis was noted in the distal third of the femoral shaft.The patient does not report any pain or symptoms related to osteolysis.No further measures of intervention will be pursued at this time.The clinic continues to monitor the patient for any symptom necessitating treatment.

• Brand Name: SYNPLUG CEMENT RESTRICTOR
• Type of Device: CEMENT OBTURATOR
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: macy nicol ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165137
• MDR Report Key: 11852554
• MDR Text Key: 252213633
• Report Number: 3001503333-2021-00003
• 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: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 804020
• Device Catalogue Number: 804020
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/20/2021
• Initial Date FDA Received: 05/19/2021
• 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
• Patient Age: 84 YR