MAUDE Adverse Event Report: NOVASTEP IMPLANT CENTROLOCK LEFT - STEP 4

Model Number	IMPLANT CENTROLOCK LEFT - STEP 4
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion : the investigations revealed 2 major mistakes: -the surgeon hasn't followed the operative technique: he's used a non locking screw instead of a locking screw -the patient has not followed the surgeon's recommendation: he has returned to his professional activities sooner than advised.The combination of both elements may explain this breakage, due to a non-respect of the products indication for use.The dhr of the different implied devices did not reveal any discrepancy against the specifications.Consequently, no complementary action is required.Initial mdr sent on the 7th of july 2020.Remark : acknowledgement available in the webtrader basis, but the incident is not visible in the maude basis.Trial to send an update of this mdr on the (b)(6) 2020 : submission result => "the initial report is missing".Due to this issue, this update has been passed on an initial submission.
Event or Problem Description
Initial information retrieved by phone on the 23th of june 2020.Additional information hereafter, dated of the (b)(6) 2020 : « implant broke post operatively.Patient works construction & returned to normal activity sooner than advised by the physician.Patient said he heard the implant break as he was on the job ».Traceability data retrieved on the (b)(6) 2020.

• Brand Name: IMPLANT CENTROLOCK LEFT - STEP 4
• Common Device Name: IMPLANT
• Manufacturer (Section D): NOVASTEP; espace performance iii; bâtiment p; saint-grégoire, 35769 ; FR 35769
• MDR Report Key: 10586212
• Report Number: 3010673777-2020-00002
• Device Sequence Number: 1166381
• Product Code: HRS
• UDI-Device Identifier: 03700879511849
• UDI-Public: 03700879511849
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K192356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2024
• Device Model Number: IMPLANT CENTROLOCK LEFT - STEP 4
• Device Catalogue Number: PL070204
• Device Lot Number: H00255
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 09/25/2020
• 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: Other