MAUDE Adverse Event Report: OSTEOMED CFX; 23MM LEFT "L" RIGID PLATE

Catalog Number 210-0216

Device Problem Material Rupture (1546)

Patient Problems Ossification (1428); Failure of Implant (1924); Loss of Range of Motion (2032)

Event Date 02/13/2018

Event Type  malfunction  

Event Description

On 03/15/2018, osteomed was notified of an incident concerning one of our implant devices.Per the distributor, seven (7) months after the bimaxillary orthognatic surgery, patient complaints a little movement of the maxilla.The same day x-ray control showed a plate rupture.One month later the surgeon removed the broken plates (right and left side).

Manufacturer Narrative

The results of the investigation show that the root cause is related to slow, or no osteogenesis, which is a user related issue.This plate is designed to provide rigid fixation of cranial bones for 6-8 weeks until osteogenesis occurs.The first plate broke nearly 7 months after implantation.This is considerably beyond the normal healing time expected for this procedure.The second plate broke between 7 and 8 months post-implantation.Per the surgeon, the patient followed the post op instructions and did not experience an trauma to the surgical site.The patient has a vitamin d deficiency.This condition does not allow the body to properly absorb calcium, and creates a diminished ability to create new bone.Specific for this case is the healing, or osteogenesis, of the facial bones in the upper jaw.It is documented that they did not heal in a timely manner, thus the plates were experiencing the stress normally handled by the bone for an extended period of time, which they are not designed to do.This lead to the broken plates.There was no lot number provided.Therefore, a review of the device history record for that particular device could not be reviwed.A two-year review of capas and ncrs did not identify any internal investigations concerning this device.The two-year review of complaints only identified one additional complaint - the other device connected to this case.The risk of the non-union of bone due to plate breakage post-implantation is covered under the failure modes and effects analysis document.The potential causes have either a severity rating of 3 or a 2.Per the risk management procedure, a rating of 3 indicates a "serious" severity level, and a rating of 2 indicates a "minor" severity level.The final risk rating for either combination is rated as a "low".The cfx ifu warns the user about use of undersized implants in areas of high functional stress, excessive bending of the plate pre-implantation, and expecting the plate system to endure excessive abnormal functional stresses.The ifu also alerts the user that the cfx plates are intended for temporary fixation only until osteogenesis occurs, and that the surgeon should provide post-operative instructions to the patient, including alerting the patient of the potential for secondary injuries to a surgical site if the patient in non-compliant.This issue will be monitored through routine trending.

• Brand Name: CFX
• Type of Device: 23MM LEFT "L" RIGID PLATE
• Manufacturer (Section D): OSTEOMED; 3885 arapaho road; addison TX 75001
• MDR Report Key: 7389806
• MDR Text Key: 104277660
• Report Number: 2027754-2018-00013
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• PMA/PMN Number: K911936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 210-0216
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR
• Patient Weight: 45