MAUDE Adverse Event Report: SEASPINE INC. CABO ANTERIOR CERVICAL PLATE SYSTEM; VARIABLE -4.0MM SELF DRILLING, 14MM

Model Number	81-1614
Medical Device Problem Codes	Mechanical Problem (1384); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Patient Problem/Medical Problem (2688)
Date of Event	05/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2020, the patient underwent anterior cervical fixation consisting of the cabo anterior cervical plate system.Seaspine was informed of a revision surgery that occurred on (b)(6) 2020 as a result of a postoperative screw migration.The case sheets from both the index surgery and revision surgery were analyzed by product monitoring along with the information received by the distributor; the 81-1614 variable - 4.0mm self drilling 14mm screw was not made available for investigation as the explant was discarded at the hospital at the time of the revision surgery.Furthermore, no x-rays were provided for analysis.The distributor noted during the revision surgery that the locking mechanism feature of the cervical plate previously implanted on (b)(6) 2020 appeared to be deployed and intact; therefore, the reported fault does not indicate a malfunction associated with the locking mechanism.The revision surgery consisted of removing the 81-1614 variable - 4.0mm self drilling 14mm screw from the 3-level construct, replacing it with qty (1) 81-1814 variable - 4.3mm self tapping 14mm screw, and redeploying the locking mechanism.
Event or Problem Description
On (b)(6) 2020, the patient underwent anterior cervical fixation consisting of the cabo anterior cervical plate system.Seaspine was informed of a revision surgery that occurred on (b)(6) 2020 as a result of a postoperative screw migration.

• Brand Name: CABO ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: VARIABLE -4.0MM SELF DRILLING, 14MM
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad, ca
• MDR Report Key: 10190199
• Report Number: 3012120772-2020-00043
• Device Sequence Number: 19059561
• Product Code: KWQ
• UDI-Device Identifier: 10889981160913
• UDI-Public: 10889981160913
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173521
• 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): 06/23/2020

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: 81-1614
• Device Catalogue Number: 81-1614
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 06/24/2020
• 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
• Patient Age: 63 YR