MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION SEASPINE SPINOUS PROCESS SYSTEM; SPINOUS PROCESS SPACER

Device Problem Premature Separation (4045)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported to seaspine on 08 dec 2021 that the seaspine spinous process system failed in five patients in the postoperative period.Please reference the following five reports to capture the 5 patients/events: 3012120772-2021-00092, 3012120772-2021-00093, 3012120772-2021-00094, this mfr report, 3012120772-2021-00096.

Manufacturer Narrative

Multiple attempts to gather additional information surrounding the events have been made; however, it is unknown if surgical intervention was required or is planned.There were no reported issues with surgical technique and it is unknown if the patient complied with post-operative warnings, all of which can contribute to post-operative failures.The product was not returned for investigation.Additionally, the part number and lot number were not provided.No x-rays were provided; therefore, the report could not be confirmed.Possible adverse events: like other spinal system implants, the following adverse events are possible.This list is not exhaustive: delayed union or nonunion (pseudarthrosis).Loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.

• Brand Name: SEASPINE SPINOUS PROCESS SYSTEM
• Type of Device: SPINOUS PROCESS SPACER
• 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: audrey mudderman ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165137
• MDR Report Key: 13108520
• MDR Text Key: 284890450
• Report Number: 3012120772-2021-00095
• Device Sequence Number: 1
• Product Code: PEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/29/2021
• 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
• Treatment: UNKNOWN INTERBODY