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

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown tibial locking compression plate (lcp)/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: van den heuvel, s.C.M.Et al (2020), combined massive allograft and intramedullary vascularized fibula transfer: the capanna technique for treatment of congenital pseudarthrosis of the tibia, acta orthopaedica, vol.91 (5), pages 605¿610 (netherlands).The aim of this study was to report a retrospective case series on the capanna technique in patients with cpt as reference for future strategies in this disease.Between november 2007 to july 2018, a total of 6 patients (7 limbs; 5 male and 1 female) with a median age of 5.5 years (3.4¿16.5) were included in the study.5 patients had unilateral cpt and 1 patient had bilateral cpt.Surgery was performed using a harvested vascularized fibula and allograft (bonebank etb-bislife, leiden, the netherlands), and fixation of the allograft was done with a large lcp plate for instant stability (figure 1a).The mean follow-up time was 5.4 years (0.9¿9.6).The following complications were reported as follows: patient 1: a (b)(6)-year-old patient developed a bilateral valgus deformity in the epiphysis of the distal tibia due to the hypotrophy of the lateral side of the distal epiphysis.Both sides were treated with an 8-plate (not specified as synthes) over the medial side of the epiphyseal plate 4 years after the initial procedure.3 years later, the 8-plates were removed and a distal epiphysiodesis was performed on the donor site to minimize the discrepancy in leg length.Patient 2: a (b)(6)-year-old patient underwent a second procedure 3 years after the initial procedure during which the lcp plate was removed because the end of the curve of the plate deviated from the bone due to growth of the distal tibia.Additionally, an 8-plate (not specified as synthes) was placed over the distal tibial epiphyseal plate to treat a valgus deformity of the distal epiphysis of the tibia due to the hypotrophy of the lateral side of the distal epiphysis.Progressive migration of the distal fibula with instability of the ankle joint was seen, which was treated by repositioning of the distal fibula with a taylor spatial frame and subsequent creation of a synostosis of the distal tibia and distal fibula.In addition, the 8-plate on the distal medial side of the left tibia was replaced as the screws had developed maximum divergence and an 8-plate was placed on the distal medial side of the right tibia (donor site) to treat the valgus of the ankle on the donor side.Patient 3: in a female patient ((b)(6)-year-old during right side surgery/(b)(6)-year-old during left side surgery), the distal anastomosis of the left tibia fractured after 15 months (fracture plate occurred as per table 3).Fusion by creating a synostosis between the distal tibia and distal remnant fibula segment was not successful at the first attempt and the patient chose to have an amputation and below-knee prosthesis.Her mobility with the below-knee prosthesis increased to such a level that she fractured the earlier operated right leg at the level of the distal screw of the lcp plate.The fracture healed after removing the lcp plate, drilling both distal tibia and fibula, and using a large spongiosa graft from a reamer irrigator aspirator (ria; depuy synthes, warsaw, in, usa) procedure from the ipsilateral femur.Latest follow-up showed a bony crossover between the distal tibia and the distal fibula.Patient 4: in a (b)(6)-year-old patient, a fracture of the distal anastomosis occurred 9 months after surgery.The fracture was treated with removal of the pseudarthrotic tissue, cancellous bone grafting from the iliac crest, and insertion of an intramedullary rush nail resulting in successful consolidation.3 years later, an 8-plate over the proximal tibial epiphyseal plate was placed to treat a valgus deformity.Patient 5: a (b)(6)-year-old patient who had a fracture of the distal anastomosis of the graft and tibia 8 months after surgery.The fracture was treated with removal of the pseudarthrotic tissue and bone grafting from the iliac crest.Bone healing occurred after 8 weeks with a synostosis between the distal anastomosis of the tibia and the remnant distal fibula.Patient 6: a (b)(6)-year-old patient had a fracture at the distal anastomosis between graft and tibia 6 months after surgery.The fracture was treated with replacement of the lcp plate and an ria procedure of the femur to harvest spongiosa bone for cross-union between the distal anastomosis of the tibia and the remnant fibula.This report is for an unknown synthes tibial locking compression plate (lcp) constructs.This report captures the reported female patient (b)(6)-year-old during left side surgery in whom the distal anastomosis of the left tibia fractured after 15 months (fracture plate occurred as per table 3).Fusion by creating a synostosis between the distal tibia and distal remnant fibula segment was not successful at the first attempt and the patient chose to have an amputation and below-knee prosthesis.This s report 6 of 7 for (b)(4).

• Brand Name: UNK - PLATES: LCP TIBIA
• 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: 13308454
• MDR Text Key: 289169303
• Report Number: 8030965-2022-00442
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 01/20/2022
• 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: 01/10/2022
• 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
• Patient Age: 16 YR
• Patient Sex: Female