MAUDE Adverse Event Report: MEDCAD OSTEOMATCH; PEEK IMPLANT 150 TO 200 SQ CM

Catalog Number ACSL-003

Device Problems Human Factors Issue (2948); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 07/24/2017

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment and not for diagnosis.Evaluation of the device could not be completed as the device was discarded after explant.A review of the device history record (dhr) was performed for the specific lot number.A review of the device's labeling and production records was also performed.Evaluation is still in progress.A follow-up report will be filed as appropriate once evaluation is complete or if additional information is obtained that was not available for the initial report.

Event Description

On (b)(6) 2017, medcad was notified by the distributor that an osteomatch peek patient-specific implant was removed from a patient.It was reported by the distributor that the device was implanted on (b)(6) 2017, and that the device was explanted on (b)(6) 2017.Per the distributor, the doctor indicated that the patient developed an infection from picking at the wound.It was reported that the device was discarded after the removal.

Manufacturer Narrative

Review of the device's production records revealed that the device was manufactured in compliance with medcad's manufacturing procedures.No nonconformities were generated during the production of this device that would contribute to the condition described in this event.Review of the device's labeling revealed that instructions for use were provided that included contraindications, warnings, and sterilization instructions to be used to ensure that the implant is sterile.Per the distributor, the patient's doctor indicated that the patient developed infection due to picking at the wound.Requests for additional information, including patient weight, were attempted on (b)(6) 2018 via phone and via email.Medcad has not received further information regarding the patient's weight from the initial reporter.

• Brand Name: OSTEOMATCH
• Type of Device: PEEK IMPLANT 150 TO 200 SQ CM
• Manufacturer (Section D): MEDCAD; 501 s. 2nd ave.; suite a-1000; dallas TX 75226
• Manufacturer (Section G): MEDCAD; 501 s. 2nd ave.; suite a-1000; dallas TX 75226
• Manufacturer Contact: estelle anuwe ; 501 s. 2nd ave.; suite a-1000; dallas, TX 75226 ; 2144538864
• MDR Report Key: 7068094
• MDR Text Key: 93247389
• Report Number: 3009196021-2017-00009
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: ACSL-003
• Device Lot Number: 171705 MAS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR