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

Model Number	10-23-0130
Medical Device Problem Codes	Mechanical Problem (1384); Noise, Audible (3273)
Health Effect - Clinical Codes	Failure of Implant (1924); Patient Problem/Medical Problem (2688)
Date of Event	08/01/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Brand Name: CORAL SPINAL SYSTEM
• Common Device Name: INLINE CONNECTOR, 5.5MM TO 5.5MM
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad, ca
• MDR Report Key: 10480444
• Report Number: 3012120772-2020-00068
• Device Sequence Number: 11363676
• Product Code: NKB
• UDI-Device Identifier: 10889981030209
• UDI-Public: 10889981030209
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 10-23-0130
• Device Catalogue Number: 10-23-0130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2020
• Initial Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention