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

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).

• Brand Name: UNK - CONSTRUCTS: LCP
• Type of Device: PLATE, 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 Key: 14564860
• MDR Text Key: 293100904
• Report Number: 8030965-2022-03589
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: PK
• Number of Events Reported: 1
• 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 Received: 06/01/2022
• 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
• Date Manufacturer Received: 05/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention