MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR

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

Patient Problems Calcium Deposits/Calcification (1758); No Code Available (3191)

Event Date 01/05/2005

Event Type  Injury  

Manufacturer Narrative

Brand name, common device name, procode, mfr, lot #, part #, udi #, 510k: this report is for an unknown dynamic hip screw (dhs)./unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluated by mfr, manufacture date: 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: pajarinen, j.Et al (2005), pertrochanteric femoral fractures treated with a dynamic hip screw or a proximal femoral nail, the journal of bone and joint surgery (br), vol.87-b no.1, page 76-81 (finland).The purpose of this retrospective study is to assess the patients¿ recovery after operative treatment of a pertrochanteric femoral fracture with either dhs or pfn, in a randomized, prospective series of 108 patients.Between october 1999 and february 2001, a total of 108 patients (27 male and 81 female) were included in the study.Fracture fixation was fixed using unknown synthes dynamic hip screw (dhs) or unknown synthes proximal femoral nail (pfn).Follow-up reviews were undertaken at 6 months and 4 months postoperatively.The following complications were reported as follows: 2 patients died in the immediate post-operative period from cardiovascular causes.Another 4 died before completion of the follow-up.2 cases of redisplacement of the fracture in both groups.4 patients had revision operations.1 case of heterotopic ossification, corresponding to pfn had been used.A (b)(6) female had not good primary reduction and screw cut-out.A (b)(6) female had good primary reduction and screw cut-out.An (b)(6) had not good primary reduction.A (b)(6) male had not good primary reduction.This report captures adverse events of surgical intervention, heterotopic ossification and re-displacement.This report is for an unknown synthes dynamic hip screw (dhs).This is report 1 of 6 for (b)(4).

• Type of Device: APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8647148
• MDR Text Key: 146276343
• Report Number: 8030965-2019-64607
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2019

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: 04/29/2019
• Initial Date FDA Received: 05/28/2019
• 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