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

Catalog Number A1059

Device Problem Decrease in Pressure (1490)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not yet received by the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A sales representative reported on behalf of the customer that an a1059 mayfield modified skull clamp lost its pressure on (b)(6) 2019.The surgeon applied the clamp on the patient, setting it to 70 pounds (lbs.) of pressure.The unit then lost pressure down to 40 lbs.Of pressure.Additional information received on (b)(6) 2019, indicating that the device was used during a posterior cervical case.The incident occurred during pin placement.Mayfield pins a1083 with lot # w1805239 were used.The pins are not available for evaluation.The patient was in the prone position.There was no known patient injury, no medical intervention required, and no surgical delay due to the product issue.

Manufacturer Narrative

The device was returned for evaluation.This unit has been tested under pressure and holds the proper amount of pressure.This is a 2014 unit with no repair history that does need some general maintenance from normal wear and tear.The swivel base has some rotational movement while in the locked position.The large starburst needed heli coils and the threads are starting to show wear.The device history record was reviewed with no abnormalities related to the reported failure.The device passed all required inspection points with no associated mrr¿s, variances or rework.The complaint was not confirmed.Device identifier #: (b)(4).

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: 8287070
• MDR Text Key: 135004621
• Report Number: 3004608878-2019-00023
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Device Lot Number: 141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Date Manufacturer Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: A1083 MAYFIELD PINS