MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Catalog Number A1059

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was not yet returned to the manufacturer for physical evaluation, therefore, the complaint reported cannot be confirmed yet.

Event Description

A sales representative reported in behalf of the customer that during a routine inspection it was found out that the a1059 mayfield modified skull clamp's swivel lock was too difficult to turn to lock, it took 2 hands to lock the device.No patient injury was reported.Additional information has been requested.

Manufacturer Narrative

Udi # (b)(4).The device was not returned for evaluation therefore the failure analysis to identify root cause to the end user's experience could not be determined.The reported complaint was not confirmed.Dhr review was not possible as the provided serial number # (b)(6) does not appear to be a valid integra identification number.No other lot or serial number was provided during the course of the complaint investigation.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.Between 05nov2019 and 30jun2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr 229048 and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period 05nov2019 through 30jun2020.Integra lifesciences contacted (b)(4), director of regulatory programs, office of product evaluation and quality and (b)(4), assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

Event Description

N/a.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: SKULL CLAMPS AND HEADREST SYSTEMS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 10278135
• MDR Text Key: 203182191
• Report Number: 3004608878-2020-00108
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

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: A1059
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 04/15/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1