MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA N/A

Catalog Number MKG-MAYFIELDND

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 10/05/2020

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

An attorney has reported that a mayfield head clamp (product id unknown) malfunctioned and severely slashed a patient's head during an unspecified neck surgery.Patient outcome or health effect is unknown; however, additional information has been requested.

Manufacturer Narrative

Additional information received from patient's medical records indicate the following: the patient underwent "c1 and c2 posterior instrumented fusion with neuro monitoring" which was also described in medical records as "c1 and c2 posterior instrumented fusion with cage graft insertion." additionally, the medical records state "patient sustained a minor skull laceration during procedure." patient outcome was recorded as follows: "the patient tolerated the procedure well and was initially managed in the icu with no evidence of worsening neurological deficits and was downgraded to floors on rigid neck collar." investigation results: the mayfield head clamp was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.A medical assessment was completed as follows: based on the complaint information received and reviewed to date, a direct correlation of laceration due to device malfunction cannot be definitively confirmed.Without conclusive evidence of device malfunction, use error may not be ruled out.In the instructions for use (ifu) for mayfield skull clamps, it cautions the user that failure to read and follow instructions furnished in the product insert may result in skull pin slippage and serious injury, such as lacerations, skull fracture, or death.It instructs the user to apply the skull clamp along the center line of the patient's head with pins entering the skull perpendicularly.Failure to properly position the patient, the skull clamp on the patient's head, fully secure all adjustment position of the skull clamp or any support device may result in patient injury.The patient's final position should be acceptable to the surgeon, taking into account the patient's anatomy, pressure points and neck flexibility and access to the surgical target.The user should carefully inspect instruments (including reusable skull pins) before and after use.Routine check and maintenance by the manufacturer to ensure proper function and extend the life and performance of the device.

Event Description

N/a.

• Brand Name: N/A
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• MDR Report Key: 11618753
• MDR Text Key: 243917031
• Report Number: 3004608878-2021-00240
• 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,other
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MKG-MAYFIELDND
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR