MAUDE Adverse Event Report: SPINEWAY SA TWIN PEAKS; IMPACTOR, TLIF CAGE

Model Number	395IT1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Problems upon removal of the impactor, this turns and blocks, not allowing easy removal.If the malfunction were to recur, it is reasonable to consider that the device would be likely to contribute to a serious injury.

• Brand Name: TWIN PEAKS
• Common Device Name: IMPACTOR, TLIF CAGE
• Manufacturer (Section D): SPINEWAY SA; 7 allée moulin berger; lyon, 69130 ; FR 69130
• MDR Report Key: 12038991
• Report Number: 3010758686-2021-00001
• Device Sequence Number: 3411372
• Product Code: MAX
• UDI-Device Identifier: 03663422605375
• UDI-Public: 3663422605375
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K152355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

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 Model Number: 395IT1
• Device Catalogue Number: 395IT1
• Device Lot Number: 214495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 06/22/2021
• 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