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

Model Number	188827107
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was investigated without the requested returned device, specific lot information, or imaging.A device evaluation could not be performed as the affected device was not returned.A device history record review could not be performed as no lot information was provided.A historical data analysis revealed one additional complaint for the product system, regarding nonunion of a patient, within the last 12 months.The root cause cannot be determined or traced back to the device with the information provided.However, non-union is a known procedural risk for lumbar spinal fusion that is often caused by patient conditions that are entirely unrelated to device performance.
Event or Problem Description
As reported from complainant: it was reported that this was a posterior fusion (l3/4/5) and plif (l4/5) performed on (b)(6), 2024.After the surgery, the pseudoarthrosis due to bone fusion failure was confirmed.The removal surgery for intervertebral cage in question and posterior screw in question was performed on (b)(6), 2024.In the surgery, after the cage was removed, the proti concorde 0° 9x7x27 was found to be damaged.The fragment was in the bone graft space of the cage and no internal remains were observed.The cause is unknown.The surgery was completed successfully with no surgical delay.No further information is available.Further additional information response from complainant: - lot number - no further information is available.- any imaging related to the (b)(6) 2024 original surgery.- no further information is available.- any imaging related to the (b)(6) 2024 removal surgery.- no further information is available.- was the device noticed to be damaged during the original surgery or on imaging? - it was noticed during the second surgery.- will the device be made available for return? - no further information is available.- patient details - age, height, weight, comorbidities, conditions - no further information is available.

• Brand Name: CONCORDE PROTI P, 9X7X27 MM
• Common Device Name: INTERBODY SPACER
• Manufacturer (Section D): TYBER MEDICAL; 83 s commerce way; bethlehem PA 18017
• Manufacturer (Section G): TYBER MEDICAL; 83 s commerce way; bethlehem PA 18017
• Manufacturer Contact: tamara lewis ; 83 s commerce way; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 19931540
• Report Number: 3012966183-2024-00009
• Device Sequence Number: 8234618
• Product Code: MAX
• UDI-Device Identifier: 00819917021103
• UDI-Public: 00819917021103
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 08/07/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 188827107
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown