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

Model Number	188827107
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• 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: tamara lewis ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 18049605
• Report Number: 3012966183-2023-00021
• Device Sequence Number: 8254297
• Product Code: MAX
• UDI-Device Identifier: 00819917021103
• UDI-Public: 00819917021103
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K130573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/01/2023

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: 188827107
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Other
• Patient Age: 69 YR
• Patient Sex: Male