MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAIL HEAD ELEMENTS; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problem Joint Dislocation (2374)

Event Date 03/16/2019

Event Type  Injury  

Manufacturer Narrative

Exact date of event is unknown, march 16, 2019 is the date the literature article was published.This report is for an unknown nail element/ 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: sancineto c., et al (2019) preliminary outcomes of proximal femur megaspacers, arthroplasty today volume 5, pages 164-171, (argentina).This retrospective study aims to describe the surgical technique: implantation of proximal femur megaspacer and show the initial results of our case series.Between may 2013 and february 2017, a total of 11 cases (5 males and 6 females) with the mean age at the time of surgery 66 years (range 48-84) with proximal femoral epiphyseal bone deficit combined with a fracture at another level and signs of infection and who underwent placement of a megaspacer were included in the study.Cephalomedullary nail (pfn® depuy synthese lfn® depuy synthes) was used.2 schanz screws of 6 mm occupying the space destined to the cephalic screws of the cephalomedullary device were used.During the follow-up, anteroposterior and lateral radiographs were performed to evaluate complications and/ or signs of a union at day 15 and day 45, month 3 month 6, and then on a quarterly basis.The following complications were reported as follows: three patients required reoperation: 2 needed an antibiotic-cemented acetabular roof to avoid further subluxation episodes.This report is for an unknown nail element.This is report 4 of 6 for (b)(4).

• Brand Name: UNK - NAIL HEAD ELEMENTS
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 9834672
• MDR Text Key: 194328321
• Report Number: 8030965-2020-01941
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention