FDA Adverse Event Injury Summary report: N

PECA® 2.0

MDR report key: 24663283 · Received March 23, 2026

Report

Report Number: 3010673777-2026-00011
Event Type: Injury
Date Received: March 23, 2026
Date of Event: December 17, 2025
Report Date: March 23, 2026
Manufacturer: NOVASTEP SAS
Product Code: HWC
UDI-DI: 03700879516356
PMA / PMN Number: K143229
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

ACCORDING TO THE INFORMATION RECEIVED, TWO PECA2.0 SCREWS WERE IMPLANTED AND SUBSEQUENTLY EXPLANTED FROM THE PATIENT AFTER A CERTAIN PERIOD OF TIME AS MENTIONNED IN THE REPORT, THEN REPLACED DUE TO PATIENT NONCOMPLIANCE. THE REPORTER COULD NOT PROVIDE ANY FURTHER INFORMATION DESPITE MULTIPLE FOLLOW-UP ATTEMPTS.

Description of Event or Problem · 0

WE HAVE RECEIVED THE INFORMATION THAT A REVISION SURGERY TOOK PLACE ON THE (B)(6) 2026 TO REMOVE THE PECA SCREWS (2 SCREWS) DUE TO PATIENT NONCOMPLIANCE. DATE OF THE FIRST SURGERY IS (B)(6) 2025, WAS COMPLETED SUCCESSFULLY ACCORDING TO THE REPORTED; ALSO THE REVISION SURGERY WAS COMPLITED SUCCESSFULLY AND NO DEFECT WAS OBSERVED ON THE EXPLANTED DEVICES. THE REVISION CONSISTED OF REPLACING THE SCREWS WITH A LISFRANC PLATE SYSTEM. NO FURTHER INFORMATIONS HAVE BEEN COMMUNICATED. TWO SCREWS ARE MENTIONED IN THIS REPORT. SINCE SECTION D ALLOWS ONLY ONE REFERENCE TO BE ENTERED, THE FULL DETAILS OF THE PRODUCTS ASSOCIATED WITH THIS EVENT ARE PROVIDED BELOW : (B)(4): PRODUCT REFRENCE. BUNION IMPLANT Ø4 LG54 : PRODUCT NAME. (B)(4) : UDI-DI. M24865 : BATCH NUMBER. EXPIRY DATE : 04/01/2030. (B)(4): PRODUCT REFRENCE. BUNION IMPLANT Ø4 LG42: PRODUCT NAME. 03700879516295:UDI-DI. M24857 : BATCH NUMBER. EXPIRY DATE: 04/01/2030.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
722482	PECA® 2.0	BUNION IMPLANT Ø4 LG54/LG42	HWC	NOVASTEP SAS	PS060054	M24865	03700879516356

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Other