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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Injury (2348); Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown constructs: plate/screws /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.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: kang j. , et al (2019) prognostic factors and clinical outcomes after treatment of periprosthetic femoral fractures using a cable-plate, hip pelvis volume 31(3), pages 166-173 (korea, south) http://dx. Doi. Org/10. 5371/hp. 2019. 31. 3. 166. This study aims to assess clinical outcomes and analyze potential prognostic factors in the treatment of pffs using the cable-plate construct. Between january 2003 and february 2016, a total of 41 patients (41 hips) 20 males and 21 females, with an average age of 67. 3±12. 1 years (range, 42-86 years of the vancouver type b1 fractures treated by osteosynthesis using the cable-plate construct for fixation were reviewed. The patients were divided into two groups postoperatively. The union group 1 (n
=
29) with 14 males and 15 females age 069. 6±12. 4 62. 0± years group ii (n
=
12) with 6 males and 6 females age 62. 0±9. 7 years the cable ready plate (zimmer, warsaw, in, usa) was used as the cable-plate system in 25 cases. When unicortical proximal locking screws were considered to be available for additional fixation,we used the ao locking compression plate (synthes gmbh, oberdorf, switzerland) in 16 cases with cable fixation of the proximal segment. All cases were treated by cable-plate construct without stem change, including a 10-hole cable-plate (n
=
17), an 8- hole cable-plate (n
=
8), a 13-hole locking compression plate (n
=
6), and an 11-hole locking compression plate (n
=
10). All previous hip arthroplasty procedures were conducted using a cementless femoral stem. The mean followup period was 31. 5±11. 6 months (range, 12-58 months). The following complications were reported as follows: healing failure of surgical treatment was observed in 12 cases (group ii), which were a delayed union (n
=
10) and nonunion (n
=
2) (fig. 3). A case of a 72-year-old female with a vancouver type b1 transverse fracture around or just distal to a well-fixed femoral stem, having severe osteoporosis with bone mineral density ¿4. 0, who visited after slip down. Underwent open reduction and internal fixation carried out with cable-plate construct follow-up x-ray 10 months after surgery showing delayed union. (fig. 3) this report is for an unknown synthes 13-hole locking compression plate and 11-hole locking compression plate. A copy of the literature article is being submitted with this medwatch. This is report 2 of 4 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: PLATE/SCREWS
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 Key10540558
MDR Text Key215473372
Report Number8030965-2020-07039
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 08/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2020
Is this an Adverse Event Report? No
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 Received08/21/2020
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

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