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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 proximal femoral nail (pfn)/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 proximal femoral nail (pfn). This is report 2 of 6 for (b)(4).
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Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
MDR Report Key8647180
MDR Text Key146280191
Report Number8030965-2019-64609
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2019
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?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/28/2019 Patient Sequence Number: 1