MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY NANOSS 3D ADVANCED BONE GRAFT SUBSTITUTE; BONE VOID FILLER

Model Number 90-300-251004

Device Problem Insufficient Information (3190)

Patient Problem Ambulation Difficulties (2544)

Event Date 08/19/2022

Event Type  Injury  

Event Description

Our distribution partner surgalign reported "pod #2 patient complains of left foot weakness.Activity level on (b)(6) 2022 was bedrest until noon.Occupational therapy noted lle weakness noted at 2 min sit to stand exercise.Physical therapy notes gait decreased cadence, foot drop left, decreased left heal strike, hip hike, step-to and trunk flexion.(b)(6) 2022 transfer to ip rehab unit for daily ot/pt care.".

Manufacturer Narrative

The device remains in patient and is not available for investigation.A dhr review was performed and the device was manufactured to specifications.This report will be updated should this information become available at a later date.

• Brand Name: NANOSS 3D ADVANCED BONE GRAFT SUBSTITUTE
• Type of Device: BONE VOID FILLER
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY; 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY; 375 river park circle; marquette MI 49855
• Manufacturer Contact: casey sumlin ; 375 river park circle; marquette, MI 49855
• MDR Report Key: 15685649
• MDR Text Key: 302567125
• Report Number: 1833824-2022-00138
• Device Sequence Number: 1
• Product Code: MQV
• UDI-Device Identifier: 00846468049560
• UDI-Public: (01)00846468049560(17)230919(10)415871
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/27/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2023
• Device Model Number: 90-300-251004
• Device Catalogue Number: 90-300-251004
• Device Lot Number: 415871
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other