MAUDE Adverse Event Report: 4WEB, INC. 4WEB OSTEOTOMY TRUSS SYSTEM; OSTEOTOMY WEDGE

Model Number	EOTS-LG2206
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned to the manufacturer for evaluation.No radiographs were provided.There was no information available on whether the patient was compliant with post-operative instructions.Review of production records did not indicate any issues related to manufacturing that may have contributed to the event.Information received indicated that supplemental fixation was not used during the initial surgery as required by 4web medical osteotomy wedge instructions for use.
Event or Problem Description
Approximately ten months following the initial surgery using a 4web osteotomy wedge, the implant started to protrude due to non-union.Revision surgery was performed in which the 4web osteotomy wedge was explanted and replaced with a plate and tibial autograft.The revision was completed successfully and the patient is doing well.

• Brand Name: 4WEB OSTEOTOMY TRUSS SYSTEM
• Common Device Name: OSTEOTOMY WEDGE
• Manufacturer (Section D): 4WEB, INC.; 2801 network boulevard; suite 620; frisco TX 75034
• MDR Report Key: 9419093
• Report Number: 3009189869-2019-00014
• Device Sequence Number: 1711558
• Product Code: HRS
• UDI-Device Identifier: 00812998024773
• UDI-Public: 00812998024773
• Combination Product (Y/N): N
• PMA/510(K) Number: K172294
• 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): 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EOTS-LG2206
• Device Catalogue Number: EOTS-LG2206
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 12/05/2019
• 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
• Patient Age: 52 YR