MAUDE Adverse Event Report: OSTEOMED PEEK; OSTEOMATCH PEEK IMPLANT 100-150 SQ CM

Catalog Number ACSM-002

Device Problem Contamination (1120)

Patient Problems Failure of Implant (1924); Post Operative Wound Infection (2446)

Event Date 02/28/2017

Event Type  Injury  

Event Description

On april 11, osteomed qa was notified of an incident with the osteomatch peek implant 100 - 150 sq cm (p/n acsm-002).This incident was initially reported to medcad, the manufacturer of this product distributed by osteomed (mdr 3009196021-2017-00001).Per the information received from medcad, a patient-specific implant (psi) was removed from a female patient due to an infection.The psi was originally implanted in (b)(6) 2016.Prior to the implantation of the peek (poly-ether-ether-ketone) psi, the patient had undergone three (3) different surgeries at the same site.In the first surgery, the original (autologous) bone flap was removed.In the second surgery, the original bone flap was re-implanted and the site became infected.In the third surgery, the patient received a polymethyl methacrylate implant and the site became infected again.It was reported that the patient has a condition called myoepithelioma, which is a benign spreading tumor that will continue to resurface if not properly removed.A surgery was performed which removed one side of the transverse sinus, removed patient's skull from the parietal and occipital region, and removed a graft from patient's shoulder to replace in the cervical region of the neck.The patient status as of (b)(6) 2017 was reported to be stable.

Manufacturer Narrative

The exact root cause is unknown.The implant was not returned for evaluation.Per the investigation completed by the manufacturer, medcad, there were no issues found within the dhr, manufacturing, or labeling that would contribute to this incident.Information obtained by medcad revealed that the patient has a condition called myoepithelioma.This is a benign spreading tumor that, if not properly removed, will continue to resurface.This product was manufactured and shipped directly to the customer.Therefore, an internal dhr was not created.The review of osteomed capa and ncrs did not identify any internal investigations for this device.The review of the complaint history identified one (1) similar complaint.A review of the osteomatch peek patient specific cranial implant instructions for use (p/n 030-1706), rev.A, provides warnings and precautions related to use, and provides validated sterilization parameters to ensure the implant is sterile.This issue will be monitored through routine trending.

• Brand Name: PEEK
• Type of Device: OSTEOMATCH PEEK IMPLANT 100-150 SQ CM
• Manufacturer (Section D): OSTEOMED; 3885 arapaho road; addison TX 75001
• MDR Report Key: 6515400
• MDR Text Key: 73492118
• Report Number: 2027754-2017-00005
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• PMA/PMN Number: K110684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: ACSM-002
• Device Lot Number: 161446 SHA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR