MAUDE Adverse Event Report: TYBER MEDICAL T-PAL PROTI

Model Number	108812208
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of the investigation, no trend was detected for expulsion/migration.There was no opened capa associated with complaint category expulsion/migration.The product was not returned for evaluation; therefore, could not be evaluated.A dhr review was performed and there were no nonconformances associated with this specific complaint type.The lot met release requirements.Complaints 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.Tyber medical complaint number: (b)(4).
Event or Problem Description
01/10/2020 updated event description: on (b)(6) 2019 mis-tlif procedure was performed to treat spinal canal stenosis in l5-s1.An x-tab and the proti t-pal large (108812208) were implanted during the procedure.After decompression was performed, the surgeon moved on to intervertebral disc dissection.The implants seemed to have been located slightly off to the posterior direction, but it was confirmed that the implants were secured to the vertebral body.The surgeon implanted a rod(s) and completed final fixation of screws.The patient was x-rayed postoperatively, and it was confirmed that the implants had been secured in place.On (b)(6) 2020 it was confirmed that the proti t-pal large in question had backed out to the posterior direction.The surgeon commented the following: this adverse event might have put pressure on the nerve.The endplates were crashed which might have created a gap between the proti t-pal large.The patient is scheduled to undergo a revision procedure on (b)(6) 2020.No further information is available.Concomitant device reported: unknown screws (part# unknown, lot# unknown, quantity unknown).Unknown rods (part# unknown, lot# unknown, quantity unknown).Unknown setscrews (part# unknown, lot# unknown, quantity unknown).This complaint involves one (1) device.
Additional Manufacturer Narrative
A product evaluation was conducted for this complaint.The evaluation did not identify any issue with the device.No capa and no trend were detected at the time of the evaluation.Complaints of this nature are monitored through tracking and trending.(b)(4) 4/30/2020.

• Brand Name: T-PAL PROTI
• Common Device Name: T-PAL PROTI
• Manufacturer (Section D): TYBER MEDICAL; 83 s commerce way; suite 310; bethlehem PA 18317
• MDR Report Key: 9688632
• Report Number: 3012966183-2020-00002
• Device Sequence Number: 14298170
• Product Code: MAX
• UDI-Device Identifier: 00819917021745
• UDI-Public: 00819917021745
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: 172185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2023
• Device Model Number: 108812208
• Device Catalogue Number: 108812208
• Device Lot Number: 135101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 05/07/2020
• 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