MAUDE Adverse Event Report: SEASPINE, INC NORTHSTAR POSTERIOR CERVICAL FUSION SYSTEM

Model Number PC2-200004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

On 12 dec 2023, seaspine was made aware of four post-op infections that had occurred over a three-month period associated with surgical cases utilizing the northstar posterior cervical fusion system.This report is for 3 of 4 patients.Two pc2-200004 rod cutters (udi: (b)(4), lots: al641538b & al639162b) were returned for investigation.This report is for lot al639162b.

Manufacturer Narrative

Two pc2-200004 rod cutters (udi: (b)(4), lots: al641538b & al639162b) were returned for investigation.Per the reporter, the surgeon suspected that contamination was present in the cutting chamber.Seaspine inspection did not observe any visible contaminants.These units had been sterilized post-procedure at the hospital and sent non-sterile via the standard complaint return process.Because of this, standard bioburden testing was infeasible.External labs were unable to test for sterility outside of a controlled contamination cleaning validation.No further evaluation can be performed.Follow-up discussions with the reporter confirm that all patients received wound washout and recovered, to her knowledge.She stated they added an additional disinfection step to their cleaning process, and the surgeon believes it could have just been patient selection.A review of complaint data over the last six years confirms these are the first reports of infection related to seaspine instrumentation.At this time there is no evidence to suggest that the instruments contributed to the reported events.This event was originally reported under 3012120772-2023-00033 without part and lot numbers listed in section d.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, including hemorrhage (bleeding); thrombosis (blood clots) leading to deep venous thrombosis or pulmonary embolism; or death.

• Brand Name: NORTHSTAR POSTERIOR CERVICAL FUSION SYSTEM
• Type of Device: NORTHSTAR
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: amanda fonseca ; 5770 armada dr.; carlsbad 92008
• MDR Report Key: 18829309
• MDR Text Key: 336858750
• Report Number: 3012120772-2024-00007
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K231654
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PC2-200004
• Device Catalogue Number: PC2-200004
• Device Lot Number: AL639162B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other