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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: LOCKING: CALCANEAL PLATE PLATE, FIXATION, BONE

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SYNTHES GMBH UNK - PLATES: LOCKING: CALCANEAL PLATE PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Impaired Healing (2378); Post Operative Wound Infection (2446); Swelling/ Edema (4577)
Event Date 11/22/2013
Event Type  Injury  
Manufacturer Narrative

Product complaint #(b)(4). Without a valid lot number the device history records review could not be completed. This report is for one (1) unknown/unk - plates: locking: calcaneal plate/part and lot numbers are unknown. Without the specific part number, the device history records review could not be completed; and the udi number is unknown. Complainant device is not expected to be returned for manufacturer review/investigation. (b)(4). 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

This report is being filed after the review of the following journal article: lian, k. Et al (2013), the mineralized collagen for the reconstruction of intra-articular calcaneal fractures with trabecular defects, biomatter, vol. 3 (4), e27250, pages 1-5 (china). This retrospective matched-pair analysis aims to assess the efficacy of mc as a bone graft substitute compared with the use of autologous iliac crest bone graft for treating displaced intraarticular calcaneal fractures. Between january 2008 through june 2012, a total of 48 patients (32 male and 16 female) with a mean age of 46 years were treated with open reduction, internal fixation, and bone grafting. Patients were divided into two groups: the treated group who were grafted with mineralized collagen (mc) and the control group who were grafted with autograft. Surgery was performed using a standard ao calcaneal plate. The follow-up time frame was ranged from 12 to 24 months with a mean follow-up at 17 months. The following complications were reported as follows: 16 patients reported pain with ambulation at final follow-up. 10 patients exhibited ankle swelling >1cm compared with the uninjured foot. 3 patients developed a secondary wound infection successfully treated with debridements and intravenous antibiotics. 4 patients experienced delayed wound healing. This report is for an unknown synthes locking calcaneal plate and unknown synthes locking calcaneal screws. This report is for one (1) unk - plates: locking: calcane. This report is 1 of 2 for (b)(4).

 
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Brand NameUNK - PLATES: LOCKING: CALCANEAL 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 
MDR Report Key11921573
MDR Text Key266976687
Report Number8030965-2021-04472
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 FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 05/06/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/02/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2021
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? Yes
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 06/02/2021 Patient Sequence Number: 1
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