MAUDE Adverse Event Report: NEUROSTRUCTURES, INC. CABO; 4.0MM VARIABLE SELF TAPPING SCREW 14MM

Model Number	81-1214
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records including material and inspection records for p/ns 81-0234 (lot no.17083608), 81-1214 (lot no.16054618), and 81-1216 (lot no.16055902 and 16059408) were reviewed.No resulting issues were identified that may have contributed to the complaint condition.The pers were reviewed for the above items with no identified pattern of failure mode.The 81-0234 (unknown lot number) referenced in (b)(4) broke during contouring with no parts returned for investigation.P/n 81-1214 (unknown lot number) potential screw breakage is listed in (b)(4) with no definitive root cause determined.No parts were returned for investigation.P/n 81-1216 is referenced in two other pers.(b)(4) (1 screw from lot no.16059408) malfunction was a breakage at the screw head during tightening.(b)(4) ((b)(4) screws of unknown lot number) indicated potential screw breakage with no definitive root cause determined.No parts were returned for investigation.The image provided clearly shows the locking mechanism missing on one side.The missing mechanism was not provided for review and cannot be retrieved for future review and assessment.Plate has significant damage but no structural failure.No marks indicating the nature of the separation of the blocking mechanisms were identified.All existing mechanisms were found to be in good working condition.Wear marks are present at the screw neck area and the screw head larger diameter feature.One of the screws exhibited more significant marks.Those mark can be a result of turning against the locking mechanism or the plate.(b)(4) of the screws were broken but no indication to the nature of the failure.Report 4 of 4.
Event or Problem Description
Surgeon had to revise an acdf patient that was just over 3 months out.Physician noted at 3 weeks that one of the screws on the bottom of the plate had backed out "one turn".He did not surgically intervene at that time.The patient later reported hearing a pop (approximately 13 weeks post-op).The patient was seen by the surgeon after this event.The x-ray revealed the bottom screw had backed out further, and both of the top screws were broken close to mid-shaft.The surgeon took the patient back to surgery and removed the plate and screws, except for the 2 broken tips which he left in the bone.The surgeon chose not to re-plate.The patient was put in a hard collar and will be monitored to see if further intervention is needed.

• Brand Name: CABO
• Common Device Name: 4.0MM VARIABLE SELF TAPPING SCREW 14MM
• Manufacturer (Section D): NEUROSTRUCTURES, INC.; 16 technology drive; suite 165; irvine CA 92618
• MDR Report Key: 7222745
• Report Number: 3008853203-2017-00012
• Device Sequence Number: 1847460
• Product Code: KWQ
• UDI-Device Identifier: 00841508101666
• UDI-Public: 841508101666
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K142060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 81-1214
• Device Lot Number: 16054618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/29/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2017
• Initial Report FDA Received Date: 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1