MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN PLATES; PLATE,FIXATION,BONE

Device Problem Migration (4003)

Patient Problems Hematoma (1884); Nerve Damage (1979); Post Operative Wound Infection (2446); Physical Asymmetry (4573)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown plates/unknown lot.Part and lot numbers are unknown; udi 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: zhong, w.Et al.(2020), imaging evaluation of nano-hydroxyapatite/ polyamide 66 strut in cervical construction after 1-level corpectomy: a retrospective study of 520 patients, european journal of medical research, vol.25(38), pages 1-8 (china) https://doi.Org/10.1186/s40001-020-00440-3.The objective of this study is to observe the radiographic characteristics of bone fusion with the n-ha/pa66 strut in cervical reconstruction using an x-ray and 3-d computed tomography examinations when necessary with the brantigan scale to devise a system for follow-up (fu) evaluation.Between june 2006 and december 2014, a total of 520 patients (271 males and 249 females) underwent one-level accf using a locking titanium plate.Implants used were titanium anterior cervical plates (johnson and johnson, co., depuy spine, ltd., raynham, ma, u.S.A.).The patients were divided into 3 groups according to radiographic date of bone graft patter.Group a, b, and c.Radiographic fu examinations, including x-ray and 3-d ct (when necessary, usually only at final fu), were performed immediately and at 3 months, 6 months and 12 months postoperatively and then annually thereafter.The following complications were reported as follows: a (b)(6) year-old male patient whose preoperative cervical mri revealed c5/6 disc herniation underwent 1-level corpectomy with an n-ha/pa66 strut.Lateral x-ray films indicated bony fusion of the autogenous bone granules filling the strut.Obvious subsidence and screw displacement were observed at the 3-month, 6-month, 12-month, and 6-year follow-up visits (c¿f).3-d ct at the 6-year follow-up (g) showed solid bone fusion, and the patient complained of no symptoms or signs a (b)(6) year-old female patient whose preoperative cervical mri revealed c4/5 disc herniation compressing the spinal cord underwent 1-level corpectomy with an n-ha/pa66 strut.Lateral x-ray films indicated bony fusion of the autogenous bone granules filling the strut, and subsidence was observed at the 6-month, 12-month, and 8-year follow-up visits.3-d ct at the 3-year and 8-year follow-up visits showed solid bone fusion type c was more often observed more with subsidence rate, segmental angle loss and cervical alignment loss than types a and b.4 patients had an incision superficial hematoma which were healed by drainage and dressing changes 3 patients had a superficial infection which were healed by dressing changes and oral antibiotics 1 patient had a recurrent laryngeal nerve injury which recovered to normal at 3 months fu.This report is for an unknown synthes titanium cervical plate.This report is for one (1) unknown plates.This is report 5 of 6 for (b)(4).

• Brand Name: UNKNOWN PLATES
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 11066301
• MDR Text Key: 223713234
• Report Number: 1526439-2020-02475
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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: 11/26/2020
• 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