MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM RAPID RESORBABLE STRUT PLATE 2 HOLESX18 HOLES-STERILE; PLATE, BONE

Catalog Number	852.421.01S
Medical Device Problem Codes	Naturally Worn (2988); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that one of the resorbable plates that was implanted during patient's craniosynostosis repair in (b)(6) 2024 was palpable and visible.The normal resorption/degradation time of these plates was approximately 12 months.There has not been a removal surgery.There were no other clinical findings.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: corrected: g1.Device history review: part# 852.421.01s.Lot # 255l524.Manufacturing site: werk bio oberdorf.Supplier: na.Release to warehouse date: 23 jan 2024.Expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.0MM RAPID RESORBABLE STRUT PLATE 2 HOLESX18 HOLES-STERILE
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf CO 4436 ; SZ 4436
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22087167
• Report Number: 8030965-2025-05218
• Device Sequence Number: 18109587
• Product Code: JEY
• UDI-Device Identifier: 10887587064352
• UDI-Public: (01)10887587064352(17)271231(10)255L524
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K062789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 852.421.01S
• Device Lot Number: 255L524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RAPIDSORB CORTSCR Ø2 L4 10U.; RAPIDSORB CORTSCR Ø2 L4 10U.; RAPIDSORB CORTSCR Ø2 L4 10U.; RAPIDSORB CORTSCR Ø2 L4 10U.; RAPIDSORB STRUT PLATE 2 2*18HO T1.2 SING.; RAPIDSORB STRUT PLATE 2 2*18HO T1.2 SING.; RAPIDSORB STRUT PLATE 2 2*18HO T1.2 SING.
• Patient Sex: Female