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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: 2.4 MM VARIABLE ANGLE LCP VOLAR RIM DISTAL RADIUS PLATE PLATE, FIXATION, BONE

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SYNTHES GMBH UNK - PLATES: 2.4 MM VARIABLE ANGLE LCP VOLAR RIM DISTAL RADIUS PLATE PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown 2. 4mm variable angle lcp volar rim distal radius plate/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k 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: bai, x, liu z, wang b, et al. (2021), shear wave elastography (swe) evaluation of asymptomatic flexor pollicis longus tendon condition after volar plate fixation for distal radius fracture, international journal of general medicine, volume 14, pages 187-193, (china). This study aimed to evaluate asymptomatic flexor pollicis longus tendon condition after volar plate fixation for distal radius fracture using shear wave elastography. From 2016¿2019, 36 patients with distal radius fractures who underwent open reduction and internal fixation with the radius distal volar locking plate were included in the study. There were 11 males and 25 females with a mean age of 62. 8 years (range
=
52¿73 years). All involved patients underwent open reduction and internal fixation with the unknown synthes 2. 4mm variable angle lcp volar rim distal radius plate. Ultrasonography was used to measure the flexor pollicis longus tendon distance to the volar plate in the involved wrists, and the thickness of the flexor pollicis longus tendon in the involved wrists was measured on shear wave elastograph sonograms taken 12 months postoperatively. Complications were reported as follows: unknown patients had asymptomatic tendon injury. 17 patients had soong grade 1 volar plate prominence. 7 patients had soong grade2 volar plate prominence. This report is for the unknown synthes 2. 4mm variable angle lcp volar rim distal radius plate. This is report 1 of 1 for (b)(4).
 
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Brand NameUNK - PLATES: 2.4 MM VARIABLE ANGLE LCP VOLAR RIM DISTAL RADIUS PLATE
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key12565241
MDR Text Key274463035
Report Number8030965-2021-08299
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2021
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?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/01/2021 Patient Sequence Number: 1
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