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

Catalog Number A1059

Device Problems Device Slipped (1584); Appropriate Term/Code Not Available (3191)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2015

Event Type  Injury  

Event Description

Patient slipped due to the a1059 skull clamp.Patient injury was reported.Additional information was requested and on 15sep2015, the following information was provided by the customer: the patient was positioned pone.The serial number of the device is (b)(4).The product will be returned to be evaluated.No additional information was provided.

Manufacturer Narrative

Integra has completed their internal investigation on (b)(6) 2015.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: the returned unit did not meet all the required functional tests.Upon disassembling, there was a lot of residue found in the locking assembly.Additionally, the internal parts were worn and need to be replaced.This device was manufactured on june 30th of 2002.Service history: date of repair: 04/08/2005 no manufacturing or design related trend has been identified.Conclusion: in summary the end users reason for return was verified as the device in question did not meet all functional testing requirements.This device was also received with a non mayfield component (80 pound torque knob).Please refer to the ifu warning label with respect to non-mayfield branded products.As we have only validated mayfield products used in conjunction with the mayfield product line, and as a result, cannot advise whether suppliers products would work properly with the mayfield line of products.Lastly general maintenance is required for the returned device for it was manufactured in 2002 last serviced in 2005.

• 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5082561
• MDR Text Key: 25997088
• Report Number: 3004608878-2015-00251
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2002
• 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
• Patient Outcome(s): Other