MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MEDPOR CUSTOMIZED IMPLANT MED

Catalog Number 54440210

Device Problem Structural Problem (2506)

Patient Problem No Patient Involvement (2645)

Event Date 02/19/2015

Event Type  malfunction  

Event Description

It was reported that the customized implant did not meet surgeon's requested specifications.On (b)(6) 2015, the sales rep confirmed that this was a patient specific implant and the original design was changed in accordance with the surgeon's preferences.However, the original design without the changes was manufactured and delivered.The device did not malfunction as it served its purpose of replacing the full thickness of the skull defect.Additional medpor was added to meet the design specs originally requested by the surgeon to meet his needs successfully.

Manufacturer Narrative

Should additional information become available, it will be provided in the supplemental report upon completion of the investigation.Device was implanted.

Manufacturer Narrative

That this event is a duplicate of (b)(4).This event is not considered to be reportable as there were no adverse consequences for the patient, no history of adverse consequences for the patient in previous similar events, and no information to indicate that adverse consequences would occur if the event were to happen again.A medpor customized cranial implant not fitting as intended and needing modification to meet surgical need does not mean that there will be complications during surgery, as it is normal practice to further contour the customized implants during surgeries to better suit the patient needs.Even if the doctor was not able to use the customized implant, the surgery can still be completed using standard back up materials such as titanium mesh, medpor non-customized implant, etc.We have reviewed the historical reportability of this device over a two year period, and there are no instances of decisions to report similar malfunctions.

Event Description

It was reported that the customized implant did not meet surgeon's requested specifications.On (b)(6) 2015, the sales rep confirmed that this was a patient specific implant and the original design was changed in accordance with the surgeon's preferences.However, the original design without the changes was manufactured and delivered.The device did not malfunction as it served its purpose of replacing the full thickness of the skull defect.Additional medpor was added to meet the design specs originally requested by the surgeon to meet his needs successfully.

• Brand Name: MEDPOR CUSTOMIZED IMPLANT MED
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer Contact: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4609054
• MDR Text Key: 5695437
• Report Number: 0002249697-2015-00767
• Device Sequence Number: 1
• Product Code: KKY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 54440210
• Device Lot Number: M09781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 45 YR