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

Catalog Number A1059

Device Problems Unstable (1667); Dull, Blunt (2407)

Patient Problem Injury (2348)

Event Date 01/07/2020

Event Type  Injury  

Manufacturer Narrative

The device was not 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.Linked to mfg number : 3004608878-2020-00081.

Event Description

1 of 2 reports.It was reported that on (b)(6) 2020, a patient fell out of the a1059 mayfield modified skull clamp.The a1047 mayfield adult reusable skull pin ¿turned out to be blunt¿.Additional information was received on (b)(6) 2020 and (b)(6) 2020 indicating that the patient was positioned prone (on the belly) for an unspecified surgery.After placement of the clamp was completed, by repositioning the patient¿s shoulder, the patient fell out of the clamp.The patient was caught by the surgeon.The patient had on one side of the head, a 15 cm over the skull and 0.5 cm deep head injury.The injury was sutured.The surgery was continued by gluing the wound of the patient (bald).The skull clamp was replaced, and the surgery was continued, and completed normally.There was a 20-minute increase in the surgery time.The skull pins were resterilized.Request for additional information has been sent.

Manufacturer Narrative

The device was returned for evaluation.The device history record 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 skull clamp tested according to manufacturer`s specifications and no failure was found.The observed condition is likely caused by improperly handling of the device.When unit is properly positioned and put under pressure unit would not have slipped.The definite root cause cannot be reliably determined.The complaint is unconfirmed.

• 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: 10277537
• MDR Text Key: 202719117
• Report Number: 3004608878-2020-00080
• 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
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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: 02/20/2020
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: A1047 MAYFIELD SKULLPINS