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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: 3.5 MM LCP ANTEROLATERAL DISTAL TIBIA PLATE PLATE, FIXATION, BONE

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SYNTHES GMBH UNK - PLATES: 3.5 MM LCP ANTEROLATERAL DISTAL TIBIA PLATE PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Nerve Damage (1979); Physical Asymmetry (4573)
Event Type  Injury  
Manufacturer Narrative

Product complaint # (b)(4). Pma/510k: this report is for an unk - plates: 3. 5 mm lcp anterolateral distal tibia 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 as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. The product was not returned. Based on the information available, it has been determined that no corrective and 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: wu d, et al. (2020), novel anterior curved incision combined with mipo for pilon fracture treatment, bmc musculoskeletal disorders, volume 21:176, pages 1-9, (china). In this study, the authors developed an improved surgical approach of curved incision on the anterior area of ankle that permits visualization of the articular surface without excessive dissection of the surrounding soft tissues. The clinical effect of the curved incision in combination with mipo for the treatment of pilon fractures was explored for the first time in this research. From december 2009 to october 2014, 17 patients who were clinically diagnosed with pilon fractures were included in the study. The mean age was 37. 4 years (2962), including 11 males and 6 females. Patients were treated with minimally invasive plate osteosynthesis (mipo) combined with curved incision on the anterior area of ankle. In all cases, the unknown synthes anterolateral distal tibia locking compression plate (lcp) was chosen for fracture fixation. During postoperative treatment and rehabilitation program, passive and active motion of ankle joint must be performed as soon as possible to achieve early functional restoration. The patients started partial weight bearing (1015 kg) as tolerated in accordance with the patients general condition. Full weight bearing was recommended after x-ray showing the fracture was consolidated. All patients underwent routine evaluations including clinical and radiographic examinations, and goniometric range of motion evaluations at 1, 3, 6, and 12 months postoperative, then once a year regularly. All patients completed long-term follow up for an average 46. 7 months (range: 2472 months). Complications were reported: 1 patient had poor reduction. Unknown patients had an articular step off with a mean of 1. 0 mm (range:0-3mm). 2 patients had superficial peroneal nerve damage, but they recovered following neurotrophic treatment. 2 patients had valgus deformity at 7 degrees and 8 degrees respectively. 14 patients had implant removal. 2 patients had arthritis. 1 of them was a (b)(6)-year-old male patient in which x-ray examinations of one-year follow-up and after implant removal indicated slight arthritis. This report is for the unknown synthes anterolateral distal tibia locking compression plate. This report is for (1) unk - plates: 3. 5 mm lcp anterolateral distal tibia plate. This report is 3 of 4 for (b)(4).

 
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Brand NameUNK - PLATES: 3.5 MM LCP ANTEROLATERAL DISTAL TIBIA PLATE
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12328807
MDR Text Key267264438
Report Number8030965-2021-06715
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 07/19/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/16/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received07/19/2021
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: 08/16/2021 Patient Sequence Number: 1
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