MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Nerve Damage (1979); Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

Pt identifier: unknown.Ages 3-17 years.Sex: 76 male and 42 female.Weight: unknown.Date of event: unknown.Implant date: unknown.Explant date: unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter phone number is unknown without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: pogorelic, z.Et al.(2017) flexible intramedullary nailing for treatment of proximal humeral and humeral shaft fractures in children: a retrospective series of 118 cases.Orthopaedics and traumatology: surgery and research.Volume 103, pages 765-770.(croatia) this retrospective study aims to investigate the clinical and radiological outcome of humeral shaft and proximal humeral fractures treated by flexible intramedullary nailing (fin) in children.From may 2002 until may 2016, 118 patients (76 male and 42 female ages 3-17 years) were treated with two unknown synthes titanium intramedullary nails under general anesthesia once reduction was achieved.Follow up examination after a mean of 77 (3-176) months.Complications were reported as follows: one intraoperative fracture of humeral shaft in patient with osteogenesis imperfecta.Two patients had neurapraxia involving the radial nerve, which resolved after several weeks with no long-term complication.Four patients had entry site skin irritations which resolved without long-term effects and did not affect the results of the treatment.Skin infections at the entry site were noted in two patients.This report is for an unknown synthes titanium elastic nail.This is report 1 of 1 for (b)(4).

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7469268
• MDR Text Key: 106845796
• Report Number: 8030965-2018-53413
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: HR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• 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: 04/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention