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U.S. Department of Health and Human Services

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

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAIL HEAD ELEMENTS: PFNA BLADE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Migration (4003)
Patient Problem Skin Irritation (2076)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown pfna blade/unknown lot. Part and lot numbers are unknown; udi number is unknown. Device available for evaluation: 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: kim sj, park hs, lee dw, lee jw (2018), is calcium phosphate augmentation a viable option for osteoporotic hip fractures?, osteoporosis international, volume 29, page 2021-2028, (south korea). The aim with this retrospective study was to measure whether augmentation with resorbable calcium phosphate cement could improve fracture stability in osteoporotic hip fractures. Between march 2014 and 2017, 82 patients underwent reduction and internal fixation with a short femoral nail for osteoporotic, unstable intertrochanteric fractures were included in the study. The average age of the patients at the time of surgery was 81. 9 years (range, 65¿99 years). Patients were divided into 2 groups: group 1, composed of 42 patients (18 males, and 24 females, mean age: 82. 3 years, mean body weight: 50. 5 kgs) treated with proximal femoral nail alone and group 2, composed of 40 patients (15 males and 25 females, mean age, 81. 6 years, mean weight: 52. 1 kgs) treated with same device combined with calcium phosphate cement for augmentation. All patients were implanted with an unknown synthes proximal femoral nail antirotation (pfna). Patients were seen for follow-up at 1, 2, 4, and 6 months and then every 6 months thereafter, with clinical and radiographic evaluations. Minimum follow-up was 6 months (average, 1. 2 years; range, 0. 5¿2. 1 years). Complications were reported as follows: group 1. 1 patient had excessive screw sliding. The patient required further intervention because of severe skin irritation. Screws were exchanged. 1 patient had excessive screw sliding and loss of reduction at 2 months after surgery. The patient underwent revision with bipolar hip replacement. (fig. 2). 1 patient had deep wound infection and required surgical debridement and a total hip replacement. The patient eventually died of renal failure. 2 patients had a superficial wound infection. 4 patients had malunion. Unknown patients had sliding of screws. Unknown patients had femoral shortening. Unknown patients had varus collapse group 2. 2 patients had a superficial wound infection. Unknown patients had sliding of screws. Unknown patients had femoral shortening. Unknown patients had varus collapse. This is report 1 of 4 for (b)(4). This report is for the unknown pfna blade.
 
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Brand NameUNK - NAIL HEAD ELEMENTS: PFNA BLADE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
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 Key9612206
MDR Text Key189490972
Report Number8030965-2020-00513
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received12/30/2019
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

Patient Treatment Data
Date Received: 01/21/2020 Patient Sequence Number: 1
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