MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY PIONEER SURGICAL TECHNOLOGY CERVALIGN PLATE SCREW; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	66-VSD-40-16
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned for this complaint.Therefore, no device investigation could be done.Batch information was provided so analysis of manufacturing records yielded no abnormalities.Repeated inquiries to gather more information about this case have not resulted in any additional information beyond what is listed in this report at this time.The following sections of this report have been left blank due to the information being unavailable or nonapplicable:.
Event or Problem Description
On (b)(6) 2021 it was reported from a surgalign rep that "screws backing out at c6 per x-ray on 3/31/21.Locking mechanism was broken/disengaged on 2 screws.C6 had broken off.Had disengaged completely on c4.Surgery needed specifically due to screw back out/plate failure".

• Brand Name: PIONEER SURGICAL TECHNOLOGY CERVALIGN PLATE SCREW
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY; 357 river park circle; marquette MI 49855
• MDR Report Key: 12704817
• Report Number: 1833824-2021-00084
• Device Sequence Number: 4538031
• Product Code: KWQ
• UDI-Device Identifier: 00846468087685
• UDI-Public: (01)00846468087685(10)358281
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/23/2025
• Device Model Number: 66-VSD-40-16
• Device Catalogue Number: SAME
• Device Lot Number: 358281
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/27/2021
• 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