MAUDE Adverse Event Report: AURORA SPINE AURORA SPINE; ZIP LP 10MM X 35MM

Model Number	103-010-035
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported verbally by vp of sales at aurora to the director of engineering.There is no written record of this event; no hospital or doctor submitted a complaint or other written communication.The doctor does not wish to explant and patient does not report pain or problems.The implants are unavailable, and neither patient records nor the xray are available.The reported "opening" is roughly defined as when the engagement teeth on the male portion of the zip implant do not hold sufficient traction or leverage over the ribs of the female portion of the zip implant.Engineering summarizes the reported failure is due to improper use of the zip removal tool to adjust an already in-place implant.The engineering analysis concludes the reported failure may only be replicated by excessive misuse of the zip removal tool to adjust in-place implants, which is specifically warned against in the zip ifu.The ifu for the zip removal tool states that any time the tool is used, the zip must be discarded in favor of a new implant.The doctor was trained to this method, and certification of the training is on file.
Event or Problem Description
On 27 may 2021, a sales representative relayed information from a doctor that two zip devices partially opened following a lumbar fusion.The partial opening is visible on xray.No patient problems reported.No explant performed.

• Brand Name: AURORA SPINE
• Common Device Name: ZIP LP 10MM X 35MM
• Manufacturer (Section D): AURORA SPINE; 1930 palomar point way; suite 103; carlsbad CA 92008
• MDR Report Key: 12072876
• Report Number: 3010326971-2021-00002
• Device Sequence Number: 20021601
• Product Code: PEK
• UDI-Device Identifier: B5211030100350
• UDI-Public: B5211030100350
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140715
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2021

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: 103-010-035
• Device Catalogue Number: 103-010-035
• Device Lot Number: 4189-9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 06/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR