MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES SKULL CLAMP; ¿COMPOSITE SERIES¿

Catalog Number A3059

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Event Description

It was reported that the device was not holding like the metal kind.Additional information received from the customer via phone on (b)(4) 2017: the customer reported that three surgeons have complained about all of the facility's a3059 skull clamps for movement and/or slippages.The customer does not know which specific a3059 skull clamp/serial number was linked with this complaint.Linked to mfg report numbers: 3004608878-2017-00223; 3004608878-2017-00224; 3004608878-2017-00225; 3004608878-2017-00226; 3004608878-2017-00227; 3004608878-2017-00229; 3004608878-2017-00230.

Manufacturer Narrative

Since customer did not know which specific a3059 skull clamp/serial number was linked with the complaint and the customer provided six of the eight serial numbers to date, this complaint was assigned one of the serial numbers provided by the customer: (b)(4).Integra has completed their internal investigation on august 16, 2017.Results: dhr review; no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points with no associated mrr¿s, variances or rework.Complaints history; a two year look back from 07/31/2015 to 07/31/2017 for this reported failure using the key phrase "not holding" for product id a3059 shows that no additional complaints were received.No new design or manufacturing trends have been identified.This issue will be monitored.Conclusion: part not returned for failure analysis.

• Brand Name: MAYFIELD COMPOSITE SERIES SKULL CLAMP
• Type of Device: ¿COMPOSITE SERIES¿
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6750725
• MDR Text Key: 81496360
• Report Number: 3004608878-2017-00228
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K142238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2017
• Initial Date FDA Received: 07/28/2017
• Supplement Dates Manufacturer Received: 08/16/2017
• Supplement Dates FDA Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2016
• 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