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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MARINER MARINER - 10889981283803

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SEASPINE ORTHOPEDICS CORPORATION MARINER MARINER - 10889981283803 Back to Search Results
Model Number MD1-100016
Device Problem Mechanical Problem (1384)
Patient Problem Insufficient Information (4580)
Event Date 12/29/2021
Event Type  Injury  
Event Description
On (b)(6) 2022, seaspine was made aware that a surgeon reported likely set screw loosening post-op. X-rays taken approximately 3 months after the revision surgery shows what appears to be 3 loose set screws. The customer noted that as of 07 april 2022, there is no revision surgery scheduled for this patient. No implants were made available for analysis as no revisions have occurred. Thus, no failure analysis has been performed for this complaint.
 
Manufacturer Narrative
The root cause of these events cannot be determined at this time as no implants were made available for analysis and no additional information surrounding the surgical technique and/or events leading up to the failures were provided. A singular cause in cases involving the md1-100016 point lock set screw loosening post-op is not evident. Identified associations with loss of construct rigidity include long constructs (including the s2ai spine segment), heavy intra operative clinical manipulation (e. G. , spinal derotation), and method/order of construct tightening.
 
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Brand NameMARINER
Type of DeviceMARINER - 10889981283803
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
joseph bautista
5770 armada dr.
carlsbad, CA 92008
7602165137
MDR Report Key14324171
MDR Text Key293153737
Report Number3012120772-2022-00018
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10889981283803
UDI-Public10889981283803
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K212692
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 05/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model NumberMD1-100016
Device Catalogue NumberMD1-100016
Was Device Available for Evaluation? No
Date Manufacturer Received04/08/2022
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

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