MAUDE Adverse Event Report: NOVASTEP SAS PECA; BEVELED COMPRESSIVE IMPLANT Ø4 LG60

Model Number	PS050160
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All the information we have is stated in the report we received; however, it includes an incorrect product reference and an incorrect lot number.We have tried to reach out for the patient to have further information, but we had no answears therfore we do not have enough informations to investigate further.
Event or Problem Description
We have received a report stating that a patient had a novastep screw (peca compressive 4.0 x 60mm-sn/a, lot number h0177a) implanted.Due to the pain experienced by the patient, a verification was performed, which led to the discovery that the implant had broken.A revision surgery is planned.No further details have been communicated to us.Mdr report #: mw5178935.We belive a mistake have been made the screw would be: beveled compressive implant ø4 lg60 that would be the following ref: ps050160.Another detail that we would like to clarify we do not have such lot number, the lot number h0177a does not exist for our products, the closest batch number would be: h01775.Therefore, we are unable to investigate this issue, as we do not have the correct reference or the appropriate lot number.

• Brand Name: PECA
• Common Device Name: BEVELED COMPRESSIVE IMPLANT Ø4 LG60
• Manufacturer (Section D): NOVASTEP SAS; 2 all jacques frimot; rennes, 35000 ; FR 35000
• Manufacturer Contact: patrick lebas ; 2 all jacques frimot; rennes, 35000 ; FR 35000
• MDR Report Key: 23933111
• Report Number: 3010673777-2025-00049
• Device Sequence Number: 9528312
• Product Code: HWC
• UDI-Device Identifier: 03700879513126
• UDI-Public: 03700879513126
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/31/2025

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
• Device Model Number: PS050160
• Device Lot Number: H01775
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Race: White