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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 Problem Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown locking calcaneal plate/unknown lot. Part and lot number are unknown; udi number is unknown. Implant date is between (b)(6) 2012 to (b)(6) 2015. 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: patil c, shetty c, (2016), our experience with operative treatment of intraarticular calcaneal fractures with calcaneal plates, international journal of orthopaedics sciences, volume 2(4), pages 381-384 (india) the purpose of this study was to determine whether open reduction and internal fixation of displaced intra-articular fractures using calcaneal plates results in better general and disease specific outcomes at 1 year after injury. From february 2012 to december 2015, 28 patients with intra-articular calcanal fractures treated by means of open reduction and internal plate fixation were included in the study. There were 23 males and 5 females with an average age of 41 years (range 14 -63 years). Primary osteosynthesis with restoration of the calcaneal shortening, loss of height, broadening and intra-articular joint restoration of subtalar joint was performed. All patients were implanted with an unknown synthes locking calcaneal plates. After the surgery, a sterile compressive elastic dressing was given. Range of motion exercises began immediately on the first postoperative day. The progressive weight-bearing was started after 8 weeks. Patients were allowed full weight-bearing after 12 weeks. The patients were followed up for a minimum 12 months after surgery (maximum follow up 3 years). Complications were reported as follows: 1 patient had a plate to be removed for subsequent successful healing process. 1 patient had an early implant removal after 3months of surgery because of severe swelling. This report is for the unknown synthes locking calcaneal plates and screws. A copy of the literature article is being submitted with this medwatch. This report is for one (1) unknown locking calcaneal plate. This is report 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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11791851
MDR Text Key264471001
Report Number8030965-2021-03707
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2021
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 Received04/13/2021
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: 05/07/2021 Patient Sequence Number: 1
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