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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PLATE, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369); Osteolysis (2377)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown synthes philos plate/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k 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: shearman, a. Et al (2015). Use of a proximal humeral locking plate for complex ankle and hindfoot fusion, the journal of foot and ankle surgery, vol. 55, pages 612-618 (united kingdom). The purpose of this study is to present the experience using proximal humeral locking plate (philos) for complex tibiotalar (tt), tibiotalocalcaneal (ttc), and tibiocalcaneal (tc) fusions. Between may 2003 to july 2011, a total of 21 patients (11 males and 10 females) with mean age of 56. 1-years range 25 to 74 years were included in the study. Fracture fixation was fixed using philos (synthes, zuchwil, switzerland). The average follow-up period was 14. 6 (median 10, range 6 to 49) months. The following complications were reported as follow: a (b)(6) year-old female with 15 coronal angular deformity and 10 sagital angular deformity who had a superficial infection which was treated with antibiotics. A (b)(6) year-old female with 30 coronal angular deformity and 15 sagital angular deformity who had a poor patient satisfaction which has mrsa non-union. A (b)(6) year-old female with 25 coronal angular deformity and 10 sagital angular deformity who had a poor patient satisfaction which has non-union and deep infection. A (b)(6) year-old male with 15 coronal angular deformity and 15 sagital angular deformity who had a poor patient satisfaction which has reactivation of charcot disease. A (b)(6) year-old female with 35 coronal angular deformity and 15 sagital angular deformity who had a loose screw requiring removal for local irritation. A (b)(6) year-old male with 20 coronal angular deformity and 5 sagital angular deformity who had a distal tibia fracture above plate. A (b)(6) year-old male with 20 coronal angular deformity and 20 sagital angular deformity who had peroneal tendonitis. A (b)(6) year-old female with 10 coronal angular deformity and 20 sagital angular deformity who had a wound breakdown 3 years after the surgery and the metalwork was removed. A (b)(6) year-old female with 30 coronal angular deformity and 5 sagital angular deformity who had a subtalar osteoarthritis. The complaint involves total 20 devices. Due to system limitation of impacted products per complaint, this complaint will be captured under 2 separate complaints as listed below: (b)(4). This report is for a (b)(6) year-old female with 25 coronal angular deformity and 10 sagital angular deformity who had a poor patient satisfaction which has non-union and deep infection. This report is for an unknown philos plate. This is report 4 of 7 for (b)(4).
 
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Type of DevicePLATE, FIXATION, BONE
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 Key8355375
MDR Text Key136728597
Report Number8030965-2019-61163
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUK
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 01/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2019
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 Received01/30/2019
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 Unkown

Patient Treatment Data
Date Received: 02/20/2019 Patient Sequence Number: 1
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