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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown small fragment lcp construct/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: thompson, n.Et al (2010), the use of minimally invasive techniques in multi-level surgery for children with cerebral palsy: preliminary results, the journal of bone and joint surgery.British volume, vol.92-b (10), pages 1442-1448, https://doi.Org/10.1302/0301-620x.92b10.24307 ((b)(6)).The aim of this prospective cohort study is to describe the preliminary results of a pilot study comparing the outcomes of minimally invasive single-event multi-level surgery with conventional multilevel procedures.A total of 10 patients with a mean age of 10.6 years (7.11 to 13.9) had minimally invasive surgery on 18 limbs.These patients were matched for ambulatory level and compared with 10 patients with a mean age of 11.4 years (7.9 to 14.4) who underwent conventional multi-level surgery on 20 limbs.In 10 patients, calcaneal osteotomies were fixed with a small fragment ao plate (synthes inc., davos, switzerland) to achieve immediate stability.An innovative technique was used for derotation osteotomy of the femur and tibia, based on closed corticotomy and fixation with the titanium elastic nails (synthes inc.).Femoral derotation osteotomy was performed in all cases while tibial derotation osteotomy in 1 case (table 1).The mean follow-up period was unknown.The following complications were reported as follows: minimally invasive group: patient 2: a (b)(6) male patient developed a transient left trochanteric bursitis.Patient 3: a (b)(6) male patient developed transient neuropathic pain in the right foot.In an unknown number of patients, there was a significant reduction of knee flexor strength (p < 0.001) at 12 months compared with pre-operatively, but improved strength in the hip abductors and knee extensors at 90° and 30°.Conventional group: patient 20: a (b)(6) female patient had failure of fixation requiring revision when she fell at home five weeks postoperatively.In an unknown number of patients, muscle strength was reduced at 12 months compared with pre-operatively in all lower-limb muscle groups, except for the hip abductors (fig.2).This report is for an unknown synthes small fragment lcp construct.It captures the reported (b)(6) male patient who developed a transient left trochanteric bursitis.A copy of the literature article is being submitted with this medwatch.This is report 4 of 7 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: SMALL FRAGMENT LCP
• Type of Device: PLATE, FIXATION, BONE
• 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 Key: 11689464
• MDR Text Key: 261675083
• Report Number: 8030965-2021-03050
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• 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
• Date Manufacturer Received: 03/30/2021
• 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
• Patient Age: 13 YR