MAUDE Adverse Event Report: INTEGRA BURLINGTON, MA, INC. PHANTOM BASE ASSEMBLY; N/A

Catalog Number CRWPBS

Device Problem Fitting Problem (2183)

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

Event Date 05/03/2016

Event Type  malfunction  

Event Description

A report was received for the crwpbs.The device was in contact with a male patient, of unknown age, during an operation.There were issues with readjustment of the device with every operation because it would not fit.Also at the end of every operation it was difficult to open the asl, the silver screw seat.There was also a defect with uchra and localizer.There was no injury to the patient however the incident did lead to an increase of surgery time by 30 minutes.The patient's outcome was reported as "o.K".

Manufacturer Narrative

Integra has completed their internal investigation on 08 jul 2016 the product was not returned for investigation so no failure analysis was conducted.A dhr review cannot be performed at this time as the lot number was not provided nor was the product sent in for inspection.This review will take place once either or has been provided a two year look back in the system for this reported failure and or related to "issues with the crw system " for this product id shows that no additional complaints were received.No new design or manufacturing trends have been identified.Conclusion: the device was not released for evaluation therefore the root cause to the end users experience could not be determined.The complaint will be reopened if additional information is obtained or the device is returned.

• Brand Name: PHANTOM BASE ASSEMBLY
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA BURLINGTON, MA, INC.; 22 terry avenue; 22 terry avenue; burlington MA 01803
• Manufacturer (Section G): INTEGRA BURLINGTON, MA, INC.; 22 terry avenue; burlington MA 01803
• Manufacturer Contact: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5667355
• MDR Text Key: 46670726
• Report Number: 1222895-2016-00006
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K944463
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CRWPBS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1