MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION MAYFIELD HEAD HOLDER; SKULLCLAMPS AND HEADREST SYSTEMS

Catalog Number XXX-HEADREST

Device Problem Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the device will be returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

The customer reported that on an unknown date, an unspecified mayfield system was too flexible and it did not allow to have "rigid" fixation of the patient's head.During set up with the mayfield points and with good tightening of the joints of the system, the unit was not stable (movement due to flexibility).Additional information has been requested.

Manufacturer Narrative

The device was not released for evaluation.A device history record review could not be performed at this time as the lot number was not provided.The complaint is unconfirmed.The root cause to the end user's experience could not be determined.

• Brand Name: MAYFIELD HEAD HOLDER
• Type of Device: SKULLCLAMPS AND HEADREST SYSTEMS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ 08536
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; plainsboro NJ 08536
• Manufacturer Contact: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7488594
• MDR Text Key: 107595118
• Report Number: 3004608878-2018-00071
• 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: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XXX-HEADREST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2018
• 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