MAUDE Adverse Event Report: ONKOS SURGICAL MY3D PERSONALIZED PELVIC RECONSTRUCTION SYSTEM; NON-LOCKING CANCELLOUS BONE SCREW, 6.5MM DIA X 90MM

Model Number	CS-65090-04M
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2023, that a patient experienced a fracture of screws which caused a disassociation of the implant from the bone and that a revision sugery was being planned to correct this issue.No addtitional information regarding this adverse event has been reported.
Additional Manufacturer Narrative
The investigation is in progress.When it is complete a supplemental mdr will be submitted accordingly.Mulitple mdrs were submitted for this adverse event: 3013450937-2023-0236.
Additional Manufacturer Narrative
After further investigation, it was identified that the device information previously entered could not be confirmed.Therefore, corrections in section d.Are required.Corrections in section d.Suspect medical device: d2.Common device name is unknown; d4.Model #, catalog #, lot#, and udi# are unknown.Patient scans were provided, and a visual inspection was performed on them.The patient scans confirmed that the two my3d personalized pelvic reconstruction non-locking cancellous bone screws were fractured in the patient.The root cause for the non-locking cancellous bone screws fracturing could not be determined for this complaint as additional information regarding the event is not known.It is unknown if the patient endured any trauma.The device was not returned for evaluation.A review of the part work order(s) could not be completed as device information is not known.A review of the patient's medical history revealed that poor bone quality and previous revision surgeries could have potentially contributed to this outcome.However, this could not be determined conclusively.A review of the part work order(s) could not be completed as the device information is not known.The following mdrs were submitted for this event: 3013450937-2023-0236; 3013450937-2023-0237; 3013450937-2023-0236-001.

• Brand Name: MY3D PERSONALIZED PELVIC RECONSTRUCTION SYSTEM
• Common Device Name: NON-LOCKING CANCELLOUS BONE SCREW, 6.5MM DIA X 90MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): PRECISION FORMS, INC.; 97 decker road; butler NJ 07405
• Manufacturer Contact: danielle pierce ; 77 e halsey rd,; parsippany, NJ 07054 ; 9732645400
• MDR Report Key: 17917359
• Report Number: 3013450937-2023-00237
• Device Sequence Number: 16886938
• Product Code: LPH
• UDI-Device Identifier: B278CS6509004M0
• UDI-Public: B278CS6509004M0
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K212815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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: CS-65090-04M
• Device Catalogue Number: CS-65090-04M
• Device Lot Number: P210565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: C22-368-0001 PATIENT SPECIFIC PROXIMAL STEM.; CS-65090-04M NON-LOCKING CANCELLOUS BONE SCREW.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female