MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PLATE/SCREWS; ORTHOSIS,PEDICLE,SPINAL FIXATION

Catalog Number UNK - CONSTRUCTS: PLATE/SCREWS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: product was not returned.This report is for an unknown constructs: plate/screws/unknown lot.Part and lot numbers are unknown; udi 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: khurana, a.Et al.(2017), outcome evaluation of minimally invasive surgery versus extensile lateral approach in management of displaced intra-articular calcaneal fractures: a randomised control trial, the foot, vol.31, pages 23-20 (india).The objective of this study was to compare the clinico-radiological outcomes of displaced intra-articular calcaneal fractures (diacfs) fixed with minimally invasive surgery (mis) technique with orif.From january 1, 2014 to december 21, 2014, a total of 70 patients with 21 closed sanders type 2 and 3 diacfs underwent either extensile lateral approach was used in the orif group or mis techniques included either percutaneous reduction or small incisions with indirect fragment manipulation.There were 49 males and 11 females with a mean age of 32.3 years.Implants used were a combination of screws and multihole calcaneal plates(synthestm titanium locking calcaneal plate and ss inortm2 armplate).The following complications were reported as follows: 1 foot had clinically significant soft tissue problems 1 patient had sural nerve injury.This delayed their rehabilitation 1 patient had an infection which delayed their rehabilitation.Insignificant marginal necrosis and maceration was initially encountered in some cases of extensile lateral group but they resolved.This report is for an unknown synthes multihole calcaneal plates and screws.

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: ORTHOSIS,PEDICLE,SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA
• MDR Report Key: 11877305
• MDR Text Key: 266267177
• Report Number: 8030965-2021-04225
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - CONSTRUCTS: PLATE/SCREWS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/25/2021
• 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