MAUDE Adverse Event Report: TYBER MEDICAL CONCORDE PROTI P, 9X7X27 MM; INTERBODY SPACERS

Model Number 188827107

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.No lot information provided by the complainant; therefore, a device history record was not conducted.A historical data review has shown only 3 complaints on record spanning 40 months.Only the current complaint has been reported for this issue.There have been 4 non-related non-conformances and no capas for this part number at this time.A biocompatibility assessment was conducted on the tyber medical device which concluded that the potential for adverse biological response following implantation of the proti interbody device is extremely low.This assessment is attached to this response letter.Therefore, with the information provided a root cause is not established.

Event Description

It was reported that on an unknown date, the sales rep was contacted by surgeon's office staff on 9/27/2023 requesting the metal composition for implants used on a patient.The rep emailed the surgeon and his staff directly after being contacted.He provided them with the requested information for depuy expedium and legacy synthes- metal composition breakdowns.They said the patient was experiencing swelling, redness and irritation in his abdomen.Potentially may be having a reaction to the implants.He was contacted again by surgeon's office this afternoon.The patient was referred to a dermatologist and surgeon's office asked if we could provide "patch test kit".This complaint involves four (4) devices.Only 1 device out of the 4 reported is made by tyber medical.

• Brand Name: CONCORDE PROTI P, 9X7X27 MM
• Type of Device: 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: tamara lewis ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 18049605
• MDR Text Key: 327093759
• Report Number: 3012966183-2023-00021
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00819917021103
• UDI-Public: 00819917021103
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 188827107
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Male