MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN BIOMATERIAL - CEMENT; POLYMETHYLMETHACRYLATE BONE CEMENT

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown biomaterial - cement/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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

Device report from (b)(6) reports an event as follows: this report is being filed after the review of the following journal article: waschke a., ullrich b., kalff r., schwarz f., (2016) cement-augmented anterior odontoid screw fixation for osteoporotic type ii odontoid fractures in elderly patients: prospective evaluation of 11 patients, european spine journal volume 25(10), pages 115¿121 (germany).This study aims to present prospectively collected data on cement augmented anterior screw fixation of osteoporotic odontoid fractures of elderly patients.Between 03/2012 and 12/2013, a total of eleven patients (8 female, 3 male, median age 83 years, range 73¿89 years) with an isolated, osteoporotic type ii odontoid fracture were treated by cement-augmented anterior odontoid screw fixation.High viscosity polymethylmethacrylate (pmma) cement (confidence spinal cement system, depuy spinetm, leeds, england) was used.Ct examination for evaluation of reduction, screw position and cement distribution were done in every patient on the first postoperative day.Cervical spine radiographs were obtained 3 and 6 months after surgery.A final thin slice ct examination for evaluation of osseous union was done 12 months after surgery in all patients.Mean clinical follow-up was 15 months (6¿34 months).The following complications were reported as follows: one patient died 6 months after surgery for other reasons than the odontoid fracture.In three cases a clinical asymptomatic cement leakage could be detected, one into the c1/2 joint and two into the longus colli muscle (fig.7).After 1-year, thin slice ct with three-dimensional reconstruction did not demonstrate solid bony fusion of the odontoid fracture in 2 patients.In these two patients, fracture gap was yet detectable without sufficient bony bridging.However, these patients had no complaints so that no further intervention was justified.This report is for an unknown depuy spine confidence spinal cement system.This is report 2 of 4 for (b)(4).

• Brand Name: UNKNOWN BIOMATERIAL - CEMENT
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; 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: 10612468
• MDR Text Key: 209349669
• Report Number: 1526439-2020-01837
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• 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: 09/07/2020
• 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