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Device Problem Break (1069)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown plate/unknown lot. Part and lot numbers 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: matsuo t et al (2018). Locking plate osteosynthesis for a femoral fracture and subsequent nonunion in a patient with osteopetrosis. International journal of surgery case reports. Volume 51. Page 395-399. (japan). This case report describes the use of a locking plate to address osteopetrotic femoral fracture with a reported nonunion. This is a case of a (b)(6) year-old man who presented with a femoral shaft fracture had a history of several previous fractures. He had been diagnosed with osteopetrosis at age 7 years. At age 15 years, his left femoral trochanter was broken as a result of the impact of jumping. At age (b)(6) years, he was admitted to another hospital with complaints of right hip pain and inability to walk. He was diagnosed with an intertrochanteric fracture of the right femur, for which he under-went skeletal traction followed by surgical open reduction with a plate and wiring. The skeletal traction caused osteomyelitis of the femoral epicondyles for which he was treated at ages 18 and 21 years. At (b)(6) years of age, a fall resulted in a shaft fracture below the plate of his right femur. Plain radiographs of the right femur showed the fracture with apparent varus deformity. An open reduction and internal fixation was performed using an unknown synthes distal femoral locking compression plate (lcp-df) on the contralateral side and unknown cerclage wiring. Screws were not used. Postoperatively, consolidation was delayed. 14 months after surgery, patient experienced sudden pain. Plain radiograph showed plate breakage and right femoral nonunion with displacement. Revision was performed with bridge plating using 2 locking compression plates. A revised unknown synthes distal femoral locking compression plate was applied on the lateral side of the right femur and a broad locking compression plate on the anterior side. At the latest follow-up (2 years and 8 months later after the revision), an antero-posterior and lateral radiographs obtained and demonstrated bone union. Breakage of the most distal screw is apparent, reflecting relative stability of the fracture. He is currently pain-free and walks without support. This report is for one (1) unknown synthes distal femoral locking compression plate. This is report 1 of 1 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 Key8197862
MDR Text Key131486513
Report Number8030965-2018-59259
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
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 11/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2018
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 Received11/30/2018
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: 12/26/2018 Patient Sequence Number: 1