MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION EXPLORER TO; HEIGHT EXPANSION, 9MM X 28MM X 7-11MM, 0 DEG

Model Number	ET1-302807
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time that the incident was reported, the cause of the infection was unknown.Only the a et1-302807 height expansion, 9mm x 28mm x 7-11mm, 0 deg was removed.The screws and rods were not removed.The implant was sent out to be cultured.No results have been provided to seaspine at the time of this report.The representative alleges that the patient was not allergic to anything and confirmed that the implant was sterilized properly.Additionally, the surgeon's practice is to submerge everything in betadine prior to placing in patients.Review of labeling: possible adverse events: serious complications associated with any surgery may occur.These include, but are not limited to: wound complications, infection, genitourinary disorders, gastrointestinal disorders, respiratory disorders; cardiovascular disorders, including myocardial infarction (heart attack) or arrythmias; neurologic injuries resulting in weakness, paralysis, numbness, tingling, or pain; vascular (blood vessel) injuries, hemorrhage (bleeding); thrombosis (blood clots) leading to deep venous thrombosis or pulmonary embolism, or death.
Event or Problem Description
A surgeon reported to his representative that they'd removed an explorer to implant on (b)(6) 2021.A et1-302807 height expansion, 9mm x 28mm x 7-11mm, 0 deg was implanted and a couple of weeks later, an infection was observed.There have been no details provided by the reporter on symptoms that lead to suspecting an infection.The implant was removed on (b)(6) 2021.Upon incising the location of the implant, purulent drainage was observed flowing from the incision.

• Brand Name: EXPLORER TO
• Common Device Name: HEIGHT EXPANSION, 9MM X 28MM X 7-11MM, 0 DEG
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• MDR Report Key: 12485025
• Report Number: 3012120772-2021-00074
• Device Sequence Number: 11848588
• Product Code: MAX
• UDI-Device Identifier: 10889981126582
• UDI-Public: 10889981126582
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K212540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2021

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
• Operator of Device: Health Professional
• Device Model Number: ET1-302807
• Device Catalogue Number: ET1-302807
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention