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

Catalog Number A1059

Device Problem Mechanical Problem (1384)

Patient Problem Laceration(s) (1946)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental report will be submitted upon completion of the investigation.

Event Description

A sales representative reported on behalf of the customer that the a1059 modified skull clamp torque screw would not hold under pressure during a posterior cervical procedure on (b)(6) 2019.The patient was in the prone position for the procedure.The incident occurred in the beginning of positioning the patient.The patient incurred a 1 to 2 cm laceration which was stapled.The operating room (or) team brought in a different skull clamp which worked as intended.There was no delay in surgery noted.

Manufacturer Narrative

Device identifier # 10381780253457.The device was returned for evaluation, therefore no issues observed.Unit cleaned per protocol.With respect to the returned unit it has passed all specific functional testing requirements, except for the lock having rotational movement when unit is not under pressure, this would not have caused a slippage; when unit is properly positioned and put under pressure unit would not have slipped.Pm maintenance and cleaning required at this time.The reported complaint not confirmed from the investigation.There was no slippage from the evaluation of the returned unit.The definite root cause of the reported condition cannot be reliably determined.

• 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: 9257845
• MDR Text Key: 178623599
• Report Number: 3004608878-2019-01062
• 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
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• 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: 10/11/2019
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1