MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CMF CUSTOMIZED IMPLANT KIT LARGE; MATERIAL, POLYTETRAFLUOROETHYLENE VITREOUS CARBON, FOR MAXILLOFACIAL RECONSTRUCT

Catalog Number 5444-0-300

Device Problems Fitting Problem (2183); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2016

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer.Additional information has been requested but not made available due hospital policy.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Pmma cranial implant did not fit patient dimensions.There was a surgical delay of about 45 minutes, but the part was ultimately used after modifications and the use of additional devices.The sales rep was present during the case.

Manufacturer Narrative

An event regarding a size/fit issue involving a cmf customized implant kit large was reported.The event was confirmed.Method & results: device evaluation and results: images during the revision surgery were provided and showed that the back of the implant sat proud and the front of the implant sat flush on the brain.Medical records received and evaluation: no patient medical records were available for review.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the investigation concluded that the images provided indicated that the implant did not fit correctly.The cmf team confirmed the surgeon requested and approved this design.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Pmma cranial implant did not fit patient dimensions.There was a surgical delay of about 45 minutes, but the part was ultimately used after modifications and the use of additional devices.The sales rep was present during the case.

• Brand Name: CMF CUSTOMIZED IMPLANT KIT LARGE
• Type of Device: MATERIAL, POLYTETRAFLUOROETHYLENE VITREOUS CARBON, FOR MAXILLOFACIAL RECONSTRUCT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5457775
• MDR Text Key: 38981841
• Report Number: 0002249697-2016-00543
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 5444-0-300
• Device Lot Number: K10401ER02OCT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2016
• 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