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

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).

• Brand Name: UNK - PLATES: LOCKING: CALCANEAL PLATE
• Type of Device: PLATE, 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 Key: 11921573
• MDR Text Key: 266976687
• Report Number: 8030965-2021-04472
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• 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 Received: 06/02/2021
• 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
• Date Manufacturer Received: 05/06/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention