MAUDE Adverse Event Report: TYBER MEDICAL T-PAL PROTI 10X10X28 MM; INTERBODY SPACERS

Model Number 108812010

Device Problems Inadequacy of Device Shape and/or Size (1583); Patient Device Interaction Problem (4001)

Patient Problem Unspecified Musculoskeletal problem (4535)

Event Date 11/01/2022

Event Type  Injury  

Event Description

It was reported that this was a tlif (l4 to l5) for the lscs on (b)(6) 2022.The surgery was completed successfully without any surgical delay.After the surgery, back-out of the cage occurred.The cause of the back-out is unknown.A revision surgery will be performed.The surgeon guessed that possible causes other than product are lack of disc dissection.No further information is available.This complaint involves one (1) device.This pc is related to (b)(4) which reports that the patient complained of pain again after the revision surgery.This pc reports that back-out of the cage occurred after the primary surgery.Then, the revision surgery was performed.It was reported that this was a l4-s discectomy and fusion (l4/5 to s) performed on (b)(6) 2022.The two cages were used at l4 and l5.The surgery was completed successfully without any surgical delay.On (b)(6) 2022, the patient complained of pain, and back-out of the cage was confirmed.The revision surgery was performed on (b)(6) 2022.The cage was removed because the posterior cage seemed to be the cause of pain.Then, decompression was performed.No further information is available.This complaint involves one (1) device.

• Brand Name: T-PAL PROTI 10X10X28 MM
• Type of Device: 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: mark schenk ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 16047794
• MDR Text Key: 306156490
• Report Number: 3012966183-2022-00036
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 108812010
• Device Catalogue Number: 108812010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other