MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: PLATE/SCREWS; PLATE, FIXATION ,BONE

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

Patient Problems Arthritis (1723); Unspecified Infection (1930); Necrosis (1971); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.Implant date is between (b)(6) 2005 to (b)(6) 2017.This report is for an unknown construct: plate/screws/unknown lot.Part and lot number 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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: zeman j., et al (2019)comparison of lcp and intramedullary nail osteosynthesis in calcaneal fractures, acta ortop bras , volume 27(6), pages 288-93 (czech republic).This study aims to compare the lcp and intramedullary nail osteosynthesis in calcaneal fractures.A total of 212 patients ( 30 females and 182 males) with 236 calcaneus fractures,mean age 39.2 years (12 - 62 years) were included in the study.From august 2005 to june 2017, out of the 236 fracture operations consisted in the use of the open reduction internal fixation (orif) method with plate using the locking calcaneal plate (depuy synthes, 325 paramount drive, raynham, ma 02767, usa) in 217 fractures.Starting in early 2014 till june 2017, a total of 19 fractures were also treated with the calcaneal c-nail method using the c-nail (medin, a.S., vlachovicka 619, 592 31 nove mesto na morave,czech republic).The patients came for regular follow-ups after 6 weeks, in months 3, 6 and 12 after surgery, and then on an annual basis.The following complications were reported as follows: - 11 patients had poor results according to aofas.- 22 patients had to undergo arthrodesis as a result of pain in the subtalar joint and development of post-traumatic arthritis in the same joint.- 13 patients had marginal skin necrosis.- 4 patients had deep wound infection.- 6 percent had poor result according to aofas.-only a minimal decrease of böhler¿s angle to 29.2 was recorded after one year in both the lcp and nail group.Synthes product: this report is for an unknown synthes locking calcaneal plate.This report is for one (1) unknown construct: plate/screws.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: PLATE, FIXATION ,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10076657
• MDR Text Key: 194643207
• Report Number: 8030965-2020-03637
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: EZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• 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: 05/13/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention