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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - CONSTRUCTS: LCP PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Loss of Range of Motion (2032); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
Additional narrative: brand name, common device name, manufacturer name, city and state, lot #, pma/510k: this report is for an unknown locking compression plate/unknown lot. Part and lot number are unknown; udi number is unknown. Device available for evaluation : complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Device evaluated by mfr and manufacturer date: 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: ali, m. Et al. (2021), outcome of minimally invasive plate osteosynthesis using locking compression plate in long bone fractures, journal of pakistan medical association, vol. 71, suppl 5(8), pages s64-s69 (pakistan). The objective of this study is to evaluate the radiological and clinical outcomes of minimally invasive plate osteosynthesis (mipo) using a locking compression plate in long bone fractures. This was a prospective study for the long bones fracture managed by mipo using a locking compression plate (lcp) in thirty patients from january to december 2017. Among 30 patients, 12 were males and 18 were females. The average age of 30 patients was 59. 5 ± 16. 72 years (range
=
21 to 91 years). The following complications were reported as follows: 1 patient had screw pull-out. The patient had revision surgery with longer plate and bone grafting. 1 patient had deep infection which was debrided and was converted to hemiarthoplasty in the second stage. 1 patient having upper limb fracture was not permitted rom due to pain however this patient had partial range of motion at 6 months postoperative follow up. 1 patient had wound dehiscence, 10 patients had no bridging of gap. 2 patients were not clinically united at 6 weeks. A similar response of clinical union was observed till 6 months this report is for an unknown locking compression plate. This is report 2 of 2 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: LCP
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14564860
MDR Text Key293100904
Report Number8030965-2022-03589
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodePK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2022
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
Date Manufacturer Received05/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/01/2022 Patient Sequence Number: 1
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