MAUDE Adverse Event Report: ADDITIVE IMPLANTS ADDITIVE IMPLANTS LOW PROFILE INSERTER INSTRUMENT INNER SHAFT

Model Number	1022-301
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On a low-profile inserter tip, the threaded portion sheared off in the implant during aggressive positioning.The surgeon could not get the implant out as it was well fixed.Additionally the threaded portion remained threaded into the implant and he could not remove that.He was able to place a screw and lock the locking mechanism without difficulty and placed a plate which he was planning on replacing anyway anteriorly and subsequently informed the hospital and the patient.
Additional Manufacturer Narrative
N/a.

• Brand Name: ADDITIVE IMPLANTS LOW PROFILE INSERTER INSTRUMENT INNER SHAFT
• Common Device Name: INSERTER INSTRUMENT
• Manufacturer (Section D): ADDITIVE IMPLANTS; east shea boulevard; suite 122; phoenix AZ 85028
• Manufacturer Contact: david castleman ; 3101 east shea boulevard; suite 122; phoenix, AZ 85028 ; 3145631665
• MDR Report Key: 14428848
• Report Number: 3013961579-2022-00001
• Device Sequence Number: 14714909
• Product Code: LXH
• UDI-Device Identifier: 00817662025773
• UDI-Public: 00817662025773
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2022

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: 1022-301
• Device Catalogue Number: 1022-301
• Device Lot Number: 210231
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 05/18/2022
• Date Device Manufactured: 04/21/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown