MAUDE Adverse Event Report: TYBER MEDICAL CONCORDER PROTI 5 DG 9X 8 X23 MM; INTERBODY SPACERS

Model Number	188823408
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Cardiovascular Dysfunction/Insufficiency (4445)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On an unknown date the patient underwent a primary procedure at a different hospital.On (b)(6) 2022 the patient underwent a plif revision procedure (l3/4/5).The surgeon took the following steps.2,000 cc of hemorrhage was recorded during decompression.Ensuing procedures up to deploying a cage was performed without an issue.After the cage was deployed, 3,500 cc of hemorrhage was recorded.While they were taking a measure to stop the hemorrhage, the patient went into cardiopulmonary arrest.They closed the incision and stopped further spine procedure.The anesthetic team took a resuscitation treatment, and an electrocardiogram showed a resuscitated cardiac status.The procedure was delayed by more than 30 minutes.The surgeon commented the following: the patient has been supported by a cardiac pacemaker due to irregular pulse.The spine revision will be rescheduled.It was not confirmed if the implants might have triggered the event.No further information is available.This complaint involves four (4) devices.
Additional Manufacturer Narrative
No device history record review performed as there was no lot information forthcoming from the complainant.The report shows that 2 liters of blood were lost prior to cage insertion.As confirmed by orthopedic surgeon consultation this does not indicate a device issue but rather vascular damage during exposure and/or disc preparation.The additional loss of 3.5l of blood during cage insertion indicates the vascular damage was not addressed following disc preparation.The investigation indicates the surgeon severely damaged vascular anatomy during exposure and/or disc preparation and failed to appropriately address the damage prior to cage insertion.This is supported by the 2l of blood loss recorded prior to cage insertion, and 3.5l of blood loss recorded following cage insertion.The orthopedic surgeon was consulted about the reported event and his response supports this conclusion.The root cause it traced to user.

• Brand Name: CONCORDER PROTI 5 DG 9X 8 X23 MM
• Common Device Name: INTERBODY SPACERS
• Manufacturer (Section D): TYBER MEDICAL; 83 south commerce way; suite 310; bethlehem PA 18017
• Manufacturer (Section G): TYBER MEDICAL; 83 south commerce way; suite 310; bethlehem PA 18017
• Manufacturer Contact: mark schenk ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 14846837
• Report Number: 3012966183-2022-00024
• Device Sequence Number: 16739668
• Product Code: MAX
• UDI-Device Identifier: 00819917020922
• UDI-Public: 00819917020922
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2022

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: 188823408
• Device Catalogue Number: 188823408
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown