MAUDE Adverse Event Report: ORTHO DEVELOPMENT PISCES; PEDICLE SCREW

Model Number	753-7545-20
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, a patient underwent surgery for spinal canal stenosis.On (b)(6) 2025, a revision was performed for screw loosening at l4 and s1 as well as dislodged set screws at l3/l4/l5.The l4 and s1 screws were replaced as well as all set screws.On(b)(6) 2025, another revision was performed to replace the set screw at l3 when it had become dislodged.(this report is 1 of 4 for the incident for screw replacement at s1 on (b)(6) 2025.).
Additional Manufacturer Narrative
The screws from the initial reoperation were returned.Upon examination, damage is consistent with using excessive force during rod reduction that could result in damage to the bone-screw thread interface.Evaluation of production records determined that the device was manufactured in accordance with applicable specifications and procedures.

• Brand Name: PISCES
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer (Section G): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer Contact: drew weaver ; 12187 s. business park drive; draper, UT 84020 ; 8015539991
• MDR Report Key: 23077169
• Report Number: 1722511-2025-00018
• Device Sequence Number: 13196079
• Product Code: NKB
• UDI-Device Identifier: 00822409043989
• UDI-Public: (01)00822409043989(17)290909(10)A403583
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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: 753-7545-20
• Device Lot Number: A403583
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male