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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEASPINE INC. CORAL SPINAL SYSTEM INLINE CONNECTOR, 5.5MM TO 5.5MM

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SEASPINE INC. CORAL SPINAL SYSTEM INLINE CONNECTOR, 5.5MM TO 5.5MM Back to Search Results
Model Number 10-23-0130
Device Problems Mechanical Problem (1384); Noise, Audible (3273)
Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)
Event Date 08/01/2020
Event Type  Injury  
Manufacturer Narrative

The 10-23-0130 inline connectors were returned for investigation and evaluated on 25 aug 2020. The set screw components of the connectors were not made available for analysis as they were discarded by the hospital. Upon review of the returned connectors, no visible damage is noted on the connector bodies to indicate how a failure may have occurred or that the cause is related to the product. The radiograph provided confirms the right connector slipped on the rod, potentially as a result of the reported loosened or disassociated set screw. Additionally, the torque handle used to final tighten the connectors was functionally tested, measured, and found to be within specification. The root cause cannot be determined at this time as the torque handle was found to be within specification, the connector bodies do not display any indication of failure or damage, and the set screws were not returned for analysis. The root cause may be related to surgical technique: system over-torqued or cross-threading of the set screw upon insertion. Review of labeling: possible adverse events bending, disassembly or fracture of implant and components loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.

 
Event Description

The patient underwent spinal surgery on (b)(6) 2020 consisting of seaspine's thoracolumbosacral pedicle screw coral spinal system. The patient reported that the hardware was "squeaking" postoperatively, which prompted a revision surgery that took place on (b)(6) 2020 to replace both previously implanted coral inline connectors. It was reported that at the time of revision, the surgeon found that the caudal screw on the right inline connector was loose.

 
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Brand NameCORAL SPINAL SYSTEM
Type of DeviceINLINE CONNECTOR, 5.5MM TO 5.5MM
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 Key10480444
MDR Text Key205315053
Report Number3012120772-2020-00068
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK120047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial
Report Date 09/01/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/01/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number10-23-0130
Device Catalogue Number10-23-0130
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/20/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2020
Was Device Evaluated By Manufacturer? Yes
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: 09/01/2020 Patient Sequence Number: 1
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