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

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

Patient Problems Abscess (1690); Fistula (1862); Bone Fracture(s) (1870); Unspecified Infection (1930); Insufficient Information (4580)

Event Date 04/09/2023

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: hagmann, a.Et al (2023), comparison of laser-sintered and milled patient-specific reconstruction plates for complications and outcomes in mandibular defects¿comparative analysis of a single-center cohort, j.Pers.Med.Vol.13 (648), pages 1-15 (germany).The study aimed to analyze whether the patient collective and the subgroups differ significantly in demographic and clinical characteristics, and thus describe any individual risk factors that may lead to the loss of the patient-specific implant.Between (b)(6) 2014 and (b)(6) 2021, a total of (b)(4)) with a mean age of 59.51 years were included in the study.All patients underwent mandibular reconstruction and were divided into two groups according to the manufacturers of the patient-specific mandibular reconstruction plates.The first group, depuy synthes, with (b)(4) with a mean age of 59.48 years, and the kls martin with (b)(4) with a mean age of 59.54 years.The following complications were reported: depuy synthes.- (b)(4) patients had fistula / abscess / infection.- (b)(4) patients had fractures.- (b)(4) had relapse.- (b)(4) patients with various indication for revision.This report is for an unknown synthes mandible plate.A copy of the literature article is being submitted with this medwatch.

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.H10 additional narrative: a1, a2, a3, a4: there are multiple patients.All known information is provided in the literature article.D1, d2, d3, d4, g4 - 510k: this report is for an unknown mandible plate/screw construct/unknown lot.Part and lot number are unknown; udi number is unknown.D6:a there are multiple unknown dates of implantation between (b)(6) 2014 and (b)(6) 2021.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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.

• Brand Name: UNK - CONSTRUCTS: MANDIBLE PLATE/SCREWS
• Type of Device: PLATE, 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: 18907446
• MDR Text Key: 337730911
• Report Number: 8030965-2024-03673
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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: 02/27/2024
• 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