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U.S. Department of Health and Human Services

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

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SYNTHES 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 Bone Fracture(s) (1870); Non-union Bone Fracture (2369); Osteolysis (2377)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown dynamic compression plate and screw constructs/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.
 
Event Description
This report is being filed after the review of the following journal article: suk k. , et al (2002) limb salvage using original low heat- treated tumor-bearing bone, clinical orthopaedics and related research number 397, pp. 385¿393 (korea, south). This study aims to evaluate the outcome and usefulness of using original low heat treated tumor-bearing bone and a conventional joint prosthesis for limb salvage. From 1994 to 1998, a total of 12 patients had wide excision and limb salvage with original low heattreated tumor-bearing bone and a conventional prosthesis. Seven of the 12 patients were male and five were female, and the mean age at surgery was 26. 1 years (range, 10¿58 years). Fixation was done using bone cement (depuy cmw 1 original bone cement, warsaw, in) and the stem of a conventional joint replacement prosthesis (depuy global shoulder system or depuy elite plus hip system). This construct then was fixed to the host bone (the normal distal portion of the femur or humerus) with a dynamic compression plate and cortical screws. The mean followup was 31. 8 months (range, 11¿62 months). The following complications were reported as follows: a case of a (b)(6) year old female had non-union. The complication rate for patients requiring revision surgery was 25. 0% (three of 12 patients). There were two cases where the original low heat-treated tumor-bearing bone was fractured and there was one case of marked absorption with nonunion, which required revision surgery. There was one patient with a hip dislocation 3 months after a total hip arthroplasty, and closed reduction was done successfully. There were two fractures of the low heat-treated tumor-bearing bone 7 months and 11 months after surgery, respectively. Both were caused by slipping accidents. One patient had osteosarcoma of the proximal humerus and the other had osteosarcoma of the proximal femur. Internal fixation was done with plate and screws. Absorption of the low heat-treated tumor-bearing bone occurred in four of the six patients with proximal humeral lesions (fig 1). Among those patients, one had severe absorption of the bone and nonunion, therefore, revision surgery was done. This report is for an unknown synthes dynamic compression plate and screw constructs. It captures reported following events: patients requiring revision surgery, two cases of original low heat-treated tumor-bearing bone fracture, one case of marked absorption with nonunion, which required revision surgery, one case of a hip dislocation 3 months after a total hip arthroplasty, two fractures of the low heat-treated tumor-bearing bone due to slipping accidents. One patient had osteosarcoma of the proximal humerus and the other had osteosarcoma of the proximal femur. Absorption of the low heat-treated tumor-bearing bone in four of the six patients with proximal humeral lesions (fig 1). Among those patients, one had severe absorption of the bone and nonunion, therefore, revision surgery was done. This is report 2 of 2 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: PLATE/SCREWS
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10977062
MDR Text Key220684746
Report Number8030965-2020-09548
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 company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
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 Received11/12/2020
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: 12/09/2020 Patient Sequence Number: 1
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