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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: PHILOS; PLATE,FIXATION,BONE

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SYNTHES GMBH UNK - PLATES: PHILOS; PLATE,FIXATION,BONE Back to Search Results
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Necrosis (1971); Insufficient Information (4580)
Event Type  Injury  
Event Description
This report is being filed after the review of the following journal article: claro, r.Et al (2023), comparative analysis of proximal humerus fracture management in elderly patients: complications of open reduction and internal fixation by shoulder surgeons and non-shoulder surgeons: a retrospective study, clin shoulder elbow xx (xx), pages 1-7 (portugal).The study aimed to assess the occurrence of complications in elderly patients with phf treated surgically using orif with a locking plate and to investigate the potential differences between patients treated by shoulder surgeons and non-shoulder surgeons.Between january 1, 2011, and december 31, 2021, a total of 83 patients (16 male and 67 female) with a mean age of 77 years were included in the study.These patients underwent open reduction and internal fixation using the philos locking plate (depuysynthes) for proximal humeral fractures.Follow-up consultations included radiographic assessments at 4 weeks, 3 months, 6 months, and 1 year, followed by annual assessments (mean follow-up is 537 days).The following complications were reported as follows: - (n=13) implant failure; - (n=4) avascular necrosis.This report is for an unknown synthes philos locking plate.A copy of the literature article is being submitted with this report.This is report 1 of 2 for (b)(4).
 
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.H10 additional narrative: 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.
 
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Brand Name
UNK - PLATES: PHILOS
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 Key19132472
MDR Text Key340452750
Report Number8030965-2024-05217
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodePO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation Physician
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 04/05/2024
Initial Date FDA Received04/18/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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