MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PLATE/SCREWS; PLATE, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Muscular Rigidity (1968); Pain (1994); Solid Tumour (4552)

Event Date 10/01/2022

Event Type  Injury  

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.This report is for an unknown construct: plate/screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: samade, r.Et al (2022), utility of 45s5 bioactive glass as bone graft substitute for cavitary defects in pediatric bone tumors: a preliminary study, j pediatr orthop vol.42 (9), pages 532¿538 (usa).The purpose of this study was to evaluate the clinical and radiographic outcomes of bioactive glass used for benign cavitary pediatric bone tumors.Between 2018 and 2020, a total of 21 patients (15 male and 6 female) with a mean age of13 years were included in the study.These patients underwent surgical curettage and grafting of benign or low-grade malignant bone tumors.In all the cases, 45s5 bioactive glass (fibergraft; prosidyan, new providence, nj) was used to fill the bone defects, and to bridge bone defect, an appropriate orthopaedic hardware plates and screws (depuy synthes, raynham, ma) was used.Mean follow up for all patients was 7 months.The following complications were reported as follows: - 1 patient with a latent or active bone lesion (a nonossifying fibroma) had painful hardware requiring hardware removal - 1 patient with an aneurysmal bone cyst had persistently painful hardware leading to planning of hardware removal - 1 patient had severe stiffness of adjacent joints - 1 patient developed a surgical site infection after treatment of an aneurysmal bone cyst.A copy of the literature article is being submitted with this medwatch.This report is for an unk - construct: plate/screws this is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18913622
• MDR Text Key: 337776481
• Report Number: 8030965-2024-03707
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention