MAUDE Adverse Event Report: SPINEFRONTIER INC A-CIFT SOLOFUSE

Model Number	01-32017-06
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Spinefrontier investigation into this matter determined that the product failure was not related to manufacturing, materials, assembly, inspection, conformance, compliance, risk mitigation or surgical procedural specifications.Misuse scenarios, overtightening of the inserter to the interbody, over impaction into the vertebrae and cross-threading, most likely caused the crack to occur.These failures are the results of user error and could have been mitigated through more careful attachment and gentle impaction.Heeding the warnings in the surgical procedure will prevent re-occurrence.A review of the a-cift fmea, accounted for inserter damaging the implant due to the cage material (peek) not being strong enough and/or improper assembly of the implant on to the inserter and the risk of the implant being damaged during insertion due to excessive impaction.Spinefrontier is considering the investigation into this matter closed, without the need for any further action.
Event or Problem Description
Spinefrontier sales representative reported that the 6mm a-cift solofuse interbody was observed to be cracked when attempting to place the screws, a mallet was used to position the implant.There was no impact to patient as a result of this occurrence.

• Brand Name: A-CIFT SOLOFUSE
• Common Device Name: A-CIFT SOLOFUSE
• Manufacturer (Section D): SPINEFRONTIER INC; 350 main st; second floor; malden MA 02148
• MDR Report Key: 8621996
• Report Number: 3005977257-2019-00007
• Device Sequence Number: 2039358
• Product Code: OVE
• UDI-Device Identifier: 00190361021575
• UDI-Public: (01)00190361021575(10)BC05
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2019

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 Model Number: 01-32017-06
• Device Lot Number: BC05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 05/17/2019
• 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