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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MARINER PEDICLE SCREW SYSTEM ILIAC SCREW

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SEASPINE ORTHOPEDICS CORPORATION MARINER PEDICLE SCREW SYSTEM ILIAC SCREW Back to Search Results
Device Problem Positioning Failure (1158)
Patient Problems Fall (1848); Bone Fracture(s) (1870); Muscle Weakness (1967); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Seaspine was made aware of this event on 30 mar 2021. At this time, no explants have been made available for investigation. The surgeon will continue to monitor the patient's recovery for any indication necessitating additional treatment. Review of labeling: possible adverse events: -pain, discomfort, or abnormal sensations due to the presence of the device -postoperative fracture due to trauma, defects, or poor bone stock.
 
Event Description
The patient underwent t6-pelvis spinal surgery on (b)(6) 2020 consisting of seaspine's mariner pedicle screw system. The patient noted a considerable fall after their six month postoperative follow up appointment, and experienced pain directly over the posterior iliac area into the hip and thigh, as well as global weakness. A ct showed perforation of the tip of the left iliac screw through the outer table of the ilium. The surgeon elected to revise the construct and remove the left iliac screw and transverse connector. In a postoperative follow up appointment on (b)(6) 2021, the patient reported significant reduction of pain in the region. The surgeon continues to monitor the patient's recovery for any indication necessitating additional treatment.
 
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Brand NameMARINER PEDICLE SCREW SYSTEM
Type of DeviceILIAC SCREW
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
macy nicol
5770 armada dr.
carlsbad, CA 92008
7602165137
MDR Report Key11742340
MDR Text Key250245273
Report Number3012120772-2021-00032
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173882
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study,user facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 04/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2021
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

Patient Treatment Data
Date Received: 04/28/2021 Patient Sequence Number: 1
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