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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEASPINE INC. MARINER PEDICLE SCREW SYSTEM SET SCREW

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SEASPINE INC. MARINER PEDICLE SCREW SYSTEM SET SCREW Back to Search Results
Model Number 41-1010
Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)
Event Date 07/20/2020
Event Type  Malfunction  
Manufacturer Narrative

No implants were made available for analysis as the screw was discarded by the facility and the set screws remain in-situ. Additionally, no x-rays were made available for evaluation. Review of similar surgical events associated with 41-1010 set screw indicate appropriate technique with the exception of final tightening re-assessment following spinal alignment procedures as is a general practice recommended by deformity surgeons. Review of labeling: possible adverse events bending, disassembly or fracture of implant and components. Loosening of spinal fixation implants may occur due to, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain. Reference: (b)(4).

 
Event Description

The patient underwent spinal surgery on (b)(6) 2020 consisting of seaspine's mariner pedicle screw system. A revision surgery was performed on (b)(6) 2020 to correct the trajectory of an s1 screw (mfg ref (b)(4)) that was reported to have been too lateral. During the revision surgery, it was discovered that quantity (4) set screws were loose at level s1/s2 (mfg ref (b)(4)). The surgeon completed the revision surgery by replacing and redirecting the s1 screw as planned, reinserting the set screw, and tightening the remaining set screws.

 
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Brand NameMARINER PEDICLE SCREW SYSTEM
Type of DeviceSET SCREW
Manufacturer (Section D)
SEASPINE INC.
5770 armada drive
carlsbad, ca
Manufacturer (Section G)
SEASPINE INC.
5770 armada drive
carlsbad, ca
Manufacturer Contact
audrey mudderman
5770 armada drive
carlsbad, ca 
2165137
MDR Report Key10491064
MDR Text Key208372241
Report Number3012120772-2020-00069
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK173882
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial
Report Date 09/03/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/03/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number41-1010
Device Catalogue Number41-1010
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2020
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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