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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI LCP PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

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SYNTHES GMBH 3.5MM TI LCP PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT Back to Search Results
Catalog Number 441.901S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Pain (1994); Malunion of Bone (4529)
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation. Initial reporter is a synthes employee. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
Device report from synthes (b)(6) reports an event as follows: it was reported that on (b)(6) 2021, the patient underwent the open reduction internal fixation surgery for the surgical neck fracture with the proximal humeral plate in question. The surgery was completed successfully. After the surgery, the patient visited the hospital for following up on (b)(6) 2021, and the surgeon checked the x-ray, and there was no problem with the progress. The patient visited the hospital again on (b)(6) 2021 reporting pain. The surgeon found that there was a spiral fracture distal to the plate and the surgical neck fracture was not united; it lost its reduction. The surgeon removed the proximal humeral plate and replaced with another implant on (b)(6) 2021. New implants were fixed with a slight displacement of the diaphysis because the nail diameter is as small as 8 millimeters for the medullary cavity. The surgery was completed successfully without any surgical delay. This report is for a philos plate. This is report 1 of 1 for (b)(4).
 
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Brand Name3.5MM TI LCP PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM
Type of DeviceAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK RARON (CH)
kanalstrasse west 30
raron 3942
SZ 3942
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12414461
MDR Text Key272454761
Report Number8030965-2021-07429
Device Sequence Number1
Product Code KTW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K011815
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,Followup
Report Date 08/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number441.901S
Device Lot Number98P0564
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 Received10/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/15/2021
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: 09/02/2021 Patient Sequence Number: 1
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