MAUDE Adverse Event Report: TYBER MEDICAL T-PAL PROTI

Catalog Number	108812007
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record review of lot 112210 was performed and there were no nonconformances associated with this event type reported for this lot.This lot met release requirements.Trends have been reviewed on a lot by lot basis for this complaint category and no trend has been detected for this lot.There was no capa associated with implant migration/expulsion.The assessment is based on information available at the time of the investigation.No product was returned by the customer.Therefore, no definitive root cause could be determined based solely on the information provided by the customer.Complaints of this nature are monitored through tracking and trending.Should a trend arise, further action will be taken.(b)(4).
Event or Problem Description
On (b)(6) 2019, a tlif (transforaminal lumbar interbody fusion) procedure (l4-5 stabilization) treating spinal stenosis was performed without a surgical delay.With regard to the initial procedure, the surgeon commented as follows: it took more time to insert the titanium cage in question compared to a peek cage.S/he hammered more than usual for inserting the cage.On (b)(6) 2019, it was reported that the cage (108812007) had backed out.Currently, the patient feels pain.The surgeon evaluated the adverse effect as "mild to moderate severity." s/he also pointed out that the patient's bone quality was less sustainable.The patient will undergo a revision surgery on (b)(6) 2019.The initial implant date was (b)(6) 2019.Explant date (b)(6) 2019.Product code: 1088-12-007, lot number 112210.Hospital: (b)(6) hospital device is not expected to be returned at this time.

• Brand Name: T-PAL PROTI
• Common Device Name: T-PAL PROTI
• Manufacturer (Section D): TYBER MEDICAL; 83 s commerce way; suite 310; bethlehem 18017
• MDR Report Key: 9224678
• Report Number: 3012966183-2019-00004
• Device Sequence Number: 1564669
• Product Code: MAX
• UDI-Device Identifier: 00819917021622
• UDI-Public: 00819917021622
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2019

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 Catalogue Number: 108812007
• Device Lot Number: 112210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/23/2019
• 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