MAUDE Adverse Event Report: TYBER MEDICAL CONCORDE PROTI 360; INTERBODY SPACER SYSTEM

Model Number	188827107
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of the investigation, there was no capa and no trends associated with this event type.The product has not been returned for evaluation, and therefore cannot be evaluated.A dhr review of lot 159309 was conducted.There was one nonconformance associated with this type of failure for this manufacturing lot.4 pieces were identified with chipped coating, and were scrapped.The lot met release requirements.Complaints of this nature are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.No further action is required at this time.(b)(4).
Event or Problem Description
"on (b)(6) 2020, mis-tlif was performed in l2/3.The procedure was delayed more than 30 minutes.On (b)(6) 2020, the surgeon reported that a removal procedure would be held because the patient's infection was suspected.On (b)(6) 2020, the procedure was performed to remove the concorde device(s) and transplant the ilium.There was no notable damage or peeling of the coating on the device in question.No further information is available.".

• Brand Name: CONCORDE PROTI 360
• Common Device Name: INTERBODY SPACER SYSTEM
• Manufacturer (Section D): TYBER MEDICAL; 83 s commerce way; suite 310; bethlehem, pa
• MDR Report Key: 10334023
• Report Number: 3012966183-2020-00005
• Device Sequence Number: 3623855
• Product Code: MAX
• UDI-Device Identifier: 00819917021103
• UDI-Public: 00819917021103
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172185
• 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

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 Expiration Date: 01/25/2024
• Device Model Number: 188827107
• Device Catalogue Number: 188827107
• Device Lot Number: 159309
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 07/28/2020
• 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