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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEASPINE, INC MARINER OUTRIGGER MARINER OUTRIGGER REVISION SYSTEM

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SEASPINE, INC MARINER OUTRIGGER MARINER OUTRIGGER REVISION SYSTEM Back to Search Results
Model Number 99-1023-12
Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2021
Event Type  malfunction  
Manufacturer Narrative
Inspection upon receiving at the manufacturer observed gouges consistent with the devices being used. Follow up with the customer representative describes the allegation of metallosis may have been an inaccurate description of what was observed, as the surgeon may have been referring to the presence of gouges (origin unconfirmed) on the connectors. There has, additionally, been no evidence to support the report of metallosis (physiologic response to implant secondary to wear debris or measured serum metal ion levels). There were no films provided to show the connectors in situ. Evaluation of the devices is ongoing.
 
Event Description
On (b)(6) 2021, a procedure was performed, at which time the referenced products were implanted for spinal deformity from t10 to the iliac spine level. During a revision surgery on (b)(6) 2021, the surgeon observed a proximal fracture above t10, so the surgeon extended the surgery to t3 using the connectors between the previous surgery and the new surgery. Also observed at the time was what the surgeon referred to as "abundant metallosis". There has been no supporting evidence provided for the finding of metallosis (physiologic response to implant secondary to wear debris or measured serum metal ion levels). Follow-up with the customer representative describes the allegation of metallosis may have been an inaccurate description of what was observed, and the surgeon may have been referring to the presence of witness marks (origin unconfirmed) on the connectors. Additionally, the side connector on one side was found 'out' and the connector on the contralateral side was observed to be loose. The spine levels covered were t10-t3, and the spine levels affected were t10 and above.
 
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Brand NameMARINER OUTRIGGER
Type of DeviceMARINER OUTRIGGER REVISION SYSTEM
Manufacturer (Section D)
SEASPINE, INC
5770 armada drive
carlsbad CA 92008
MDR Report Key12426102
MDR Text Key280590887
Report Number3012120772-2021-00070
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10889981184940
UDI-Public10889981184940
Combination Product (y/n)N
PMA/PMN Number
K183639
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 09/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number99-1023-12
Device Catalogue Number99-1023-12
Device Lot NumberTE129574F
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/03/2021 Patient Sequence Number: 1
Treatment
99-1016-12 PARALLEL, CLOSED/SIDE-LOADING, 8MM
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