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

Device Problem Device Slipped (1584)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: cho, u., byun, y.S., suh, j.D., yoo, j.(2021), osteoperiosteal decortication and autogenous cancellous bone graft combined with bridge plating for non-hypertrophic diaphyseal nonunion, clinics in orthopedic surgery, vol.13, pages 301-306 (south korea).The aim of this study was to evaluate results of osteoperiosteal decortication and autogenous cancellous bone graft combined with a bridge plating technique in atrophic and oligotrophic femoral and tibial diaphyseal nonunion.We retrospectively reviewed 31 patients with atrophic or oligotrophic femoral and tibial diaphyseal nonunion treated with osteoperiosteal decortication and autogenous cancellous bone graft between january 2008 and december 2018.Seventeen nonunion cases with implant breakage or loosening and 1 nonunion case with malalignment were stabilized with 10- to 12-hole large fragment locking compression plates (lcp) (7 cases), 7- and 9-hole condylar blade plates (2 cases), or 9- to 12-hole lcp distal femur (8 cases) using a bridge plating technique after removal of the existing implants and correction of any malalignment.Twelve nonunion cases with a lack of stability without implant breakage or loosening were augmented by supplemental fixation with 6- to 10-hole small fragment or reconstruction lcp.One nonunion was fixed with a locked intramedullary nail and showed adequate stability without further support for improving stability.There were 20 men and 11 women, and the mean age of patients was 51.7 years (range, 19¿79 years).The average follow-up period was 33.3 months (range, 8¿108 months).The following complications were reported: in 1 patient, union failed due to implant loosening with absorbed bone graft, and solid union was achieved by an additional surgery for stable fixation with a new plate, osteoperiosteal decortication, and autogenous cancellous bone graft.This report is for an unknown synthes lcp construct.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: brand name, common device name, manufacturer name, city, and state, lot #, pma/510k: this report is for an unknown lcp plate/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date: date of implant is an unknown date between january 2008 and december 2018.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter: fax number reported as (b)(6).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.

• Brand Name: UNK - PLATES: 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: 14564861
• MDR Text Key: 293099948
• Report Number: 8030965-2022-03591
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• 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?: Yes
• 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