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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: 2.7 MM LCP PLATE,FIXATION,BONE

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SYNTHES GMBH UNK - PLATES: 2.7 MM LCP PLATE,FIXATION,BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Arthritis (1723)
Event Type  Injury  
Manufacturer Narrative

Product complaint # (b)(4). 510k: this report is for an unk - plates: 2. 7 mm lcp/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 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: jo s, et al. (2017), the result of using an additional mini-locking plate for tibial pilon fractures, journal of the korean fracture society, volume 30, number 2, pages 75-82, ((b)(6)). The purpose of this study is to evaluate the usefulness of an additional 2. 7 mm mini-locking plate for tibial pilon fractures. Between september 2012 and april 2014, 21 patients who were treated with a 2. 7 mm mini-locking plate via the anterolateral approach for tibial pilon fractures were included in the study. There were 14 males and 7 females with a mean age of 43. 85 years. The patients underwent surgery in 2 stages. Stage 1 surgery was performed within 24 hours after injury. In case of a distal fibula fracture, it was first fixed using a plate. An external fixation was then performed using a competitor¿s external fixator to restore and maintain the length of the tibia. At this time, k-steel wire was used as needed to stabilize the joint surface. On average 16 days (12-25 days) after stage 1 surgery, stage 2 surgery was performed. The external fixator was removed and then the fixation of the anterior/lateral bone fragment of the tibia was performed using an unknown synthes 2. 7 mm mini-locking plate. Thereafter, plate fixation using minimally invasive plate fixation was conducted through the medial approach using an unknown synthes medial distal locking plate. After the second stage operation, the upper and lower limbs were fixed using a plaster splint, and partial weight-bearing gait was performed from 8 to 12 weeks after the operation, followed by full weight-bearing gait after 12 weeks. Complications were reported: case 2, a (b)(6) year-old male had a post-traumatic ankle arthritis and a fair radiographic reduction of the articular surface. Case 3, a (b)(6) year-old male had a post-traumatic ankle arthritis and a fair radiographic reduction of the articular surface. Case 6, a (b)(6) year-old male had a fair radiographic reduction of the articular surface. Case 11, a (b)(6) year-old female had a fair radiographic reduction of the articular surface. Case 13, a (b)(6) year-old female had a mild stiff ankle with no pain. Case 20, a (b)(6) year-old male had a post-traumatic ankle arthritis and a poor radiographic reduction of the articular surface. This report is for the unknown synthes 2. 7 mm mini-locking plate and the unknown synthes medial distal tibia locking plate. This report is for (1) unk - plates: 2. 7 mm lcp. This report is 8 of 9 for (b)(4).

 
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Brand NameUNK - PLATES: 2.7 MM LCP
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 Key12361098
MDR Text Key267929537
Report Number8030965-2021-07133
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,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 07/28/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/24/2021
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 Received07/28/2021
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: 08/24/2021 Patient Sequence Number: 1
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