MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION MAYFIELD SKULL CLAMP; HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Device Problems Break (1069); Loose or Intermittent Connection (1371); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2017

Event Type  malfunction  

Event Description

A site biomed representative reported that during a cervical spinal fusion procedure there was a 2-3cm inaccuracy during navigation.They performed a second patient scan which did not resolve the inaccuracy.The surgery was continued with no reported impact to the patient.During onsite testing of the navigation system and instrumentation the medtronic rep was unable to reproduce the reported inaccuracy with medtronic equipment.It was determined that the mayfield arm caused the reported inaccuracy as it was broken and was still loose after being tightened.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MAYFIELD SKULL CLAMP
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION
• MDR Report Key: 17537430
• MDR Text Key: 321182397
• Report Number: MW5144308
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1