MAUDE Adverse Event Report: TYBER MEDICAL T-PAL PROTI 360; INTERBODY SPACER SYSTEM

Model Number	108812010
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of investigation, there was no capa and no trends associated with this event type.The product has not yet been returned for evaluation, and therefore, the investigation is still pending.A review of the lot was conducted and found no non-conformance associated with this specific complaint type.The lot met release requirements.Complaints of this nature are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continous improvement process.No further action is required at this time.Complaint number: (b)(4).
Event or Problem Description
"for the case on (b)(6) 2020, a 10mm proti cage (108812010 lot) needed to be condemned as the cage disengaged from the advanced applicator.Parts of the advanced applicator are listed as follows, advanced applicator inner shaft (03.812.521) + advanced applicator outer shaft (03.812.520)+ applicator knob (03.812.004).The surgeon used applicator for 10 mm trial in l5-s1, the applicator knob couldn't be turned and complained the applicator end was too bulky and requested to change to advanced applicator for 10mm trial and the implant.A great resistance was encountered when the 10mm proti cage was being inserted.Little progress was observed even surgeon hammered hardly with mallet.Then the surgeon turned the applicator knob to an open position for the implant to turn.Surgeon then hammered again to turn the proti cage.The cage started to turn as shown in xray, surgeon hammered hardly several times in order to fully turn the cage.Suddenly, the cage broke through the anterior annulus and went anteriorly.Surgeon grabbed the advanced applicator and found that it has already detached from the cage.Removal tool was attempt to grab the implant, yet, it was located too anteriorly which removal tools couldn't reach.The disengaged implant was removed through another incision from anterior approach.Synfix evolution was used to fuse l5-s1.Surgeon would like us to investigate why the cage disengaged from the advanced applicator.This complaint involves one (1) device.".
Additional Manufacturer Narrative
Customer is unable to return device at this time due to covid-19 restrictions.However, the customer provided the results of their investigation of the complaint device.A visual and functional investigation did not detect any major issues with the returned items.There is normal wear and tear and the devices could be used as intended.The complaint noted that the surgeon "hammered hardly with mallet".The surgical technique states that hammering should be "controlled and light".The need of hard hammering to insert and turn the cage is unusual and should be avoided.Hard hammering can potentially lead to a situation where the cage breaks through the anterior wall.A review of the x-rays also showed that the implant was already over-pivoted.In this situation it can potentially happen that the cage disengages from the applicator as described in the complaint.Insufficiently removed disc material might be the cause of the described issues.The investigation did not discover any issues related to instruments or implant.No capa and no trends have been identified.Complaints of this nature are monitored through tracking and trending.(b)(4).

• Brand Name: T-PAL PROTI 360
• Common Device Name: INTERBODY SPACER SYSTEM
• Manufacturer (Section D): TYBER MEDICAL; 83 s commerce way; suite 310; bethlehem PA 18017
• MDR Report Key: 10784610
• Report Number: 3012966183-2020-00006
• Device Sequence Number: 17093541
• Product Code: MAX
• UDI-Device Identifier: 00819917021653
• UDI-Public: 00819917021653
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K172185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020

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: 10/26/2023
• Device Model Number: 108812010
• Device Catalogue Number: 108812010
• Device Lot Number: 112213
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 12/17/2020
• 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