MAUDE Adverse Event Report: SYNTHES USA PRODUCTS, LLC T-PAL INSERTER; INTEVERTEBRAL FUSION DEVICE W/BONE GRAFT

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2018

Event Type  malfunction  

Event Description

Cage was positioned.When disengaged, the t-pal inserter did not release.

• Brand Name: T-PAL INSERTER
• Type of Device: INTEVERTEBRAL FUSION DEVICE W/BONE GRAFT
• Manufacturer (Section D): SYNTHES USA PRODUCTS, LLC; 325 paramount dr.; raynham MA 02767
• MDR Report Key: 8180673
• MDR Text Key: 131180630
• Report Number: MW5082280
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 72