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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: LAG ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH UNK - SCREWS: LAG ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Physical Asymmetry (4573)
Event Type  Injury  
Manufacturer Narrative
Additional narrative: g4-510k: this report is for an unknown lag screw/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: kang, j. W. Et al. (2021), tips and tricks to achieve osteotomy healing and prevent refracture after ulnar shortening osteotomy, journal of orthopaedic surgery and research, vol. 16(110), pages 1-11 (south korea) this study aimed to evaluate the advantages of guided osteotomy for parallel osteotomy and reduction osteotomies, healing over freehand osteotomy. It also aimed to identify surgical factors affecting healing after diaphyseal ulnar shortening osteotomy (uso). Between june 2005 and march 2016, freehand osteotomy was performed for group 1 and was fixed using a 3. 5-mm limited contact-dynamic (lc-dcp; dupuy-synthes, paoli, pa, usa) or locking (lcp; dupuy-synthes, paoli, pa, usa) compression plate, after manual reduction. In group 2, guided osteotomy was performed with a 2. 7-mm (dupuy-synthes, paoli, pa, usa) or 3. 5-mm (acumed, hillsboro, or, usa) lcp-based ulna osteotomy system. The patients were aged between 17 and 68 years. There were 78 males and 58 females. The patients were followed-up for an average of 73. 5 (range: 29. 7¿160. 7) months. The following complications were reported as follows: group 1: 11 patients had delayed unions. Three of the 11 delayed unions in group 1 (freehand osteotomy) were accompanied by screw loosening. 2 patients had refractures after plate removal. All osteotomy unions were achieved in all wrists by the last follow-up visit, without revision surgery. Group 2: 6 patients had delayed unions. One of six delayed unions (guided osteotomy) ) were accompanied by screw loosening. 1 patient had a refracture after plate removal. All osteotomy unions were achieved in all wrists by the last follow-up visit, without revision surgery. The lc-dcp plate lengthened the time to consolidation. Serial radiographs of a freehand osteotomy with unparallel osteotomy surfaces and a long osteotomy reduction gap. Immediate postoperative radiograph demonstrating that the lag screw could not compress a long osteotomy reduction gap. After 2 months, bone defect still exists. At 6 months, the osteotomy is united. The complete osteotomy consolidation is achieved at 22 months this report is for an unknown synthes lag screw. It captures the reported event of lag screw could not compress a long osteotomy reduction gap. After 2 months, bone defect still exists. A copy of the literature article is being submitted with this medwatch. This is report 8 of 8 for pc (b)(4).
 
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Brand NameUNK - SCREWS: LAG
Type of DeviceROD, FIXATION, INTRAMEDULLARY
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 Key11499189
MDR Text Key247006723
Report Number8030965-2021-02048
Device Sequence Number1
Product Code HSB
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 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2021
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 Received02/18/2021
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: 03/16/2021 Patient Sequence Number: 1
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