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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAILS ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAILS ROD, FIXATION, INTRAMEDULLARY Back to Search Results
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
A total of 11 cases (5 males and 6 females) with the mean age at the time of surgery 66 years (range 48-84). Exact date of event is unknown, (b)(6) 2019 is the date the literature article was published. This report is for an unknown nail/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. This is report 3 of 6 for (b)(4).
 
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Brand NameUNK - NAILS
Type of DeviceROD, 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 Key9834651
MDR Text Key193648867
Report Number8030965-2020-01940
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAR
Number of Events Reported1
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
Date FDA Received03/16/2020
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 Received02/18/2020
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: 03/16/2020 Patient Sequence Number: 1
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