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

Catalog Number XXX-MAYFIELD SKULL CLAMP

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

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

This report is 2 of 2 for the malfunction of the device reported in the article, which is linked to 3004608878-2021-00590: journal of medical case reports (2021) published an article: "skull fracture and epidural hematoma caused by use of a mayfield skull clamp in an adult patient with chronic hemodialysis: a case report" background: mayfield skull clamps are widely used and indispensable in current neurosurgery.Complications such as skull fractures or intracranial hematoma from using a mayfield skull clamp have largely been reported in the pediatric population, are likely related to the relative thinness of the skull, such as in patients with hydrocephalus, and are extremely rare in adults.Here, we report a case of skull fracture and epidural hematoma caused by a mayfield skull clamp used for posterior decompression surgery in an adult patient with chronic hemodialysis.Case presentation: a (b)(6) asian male patient with a history of dialysis-dependent chronic renal failure over 36 years suffered from severe cervical myelopathy.Neurological examination and radiographic images revealed cervical spondylotic myelopathy due to dialysis-related spondyloarthropathy.Laminoplasty was planned on patient consent.A mayfield skull clamp was applied with the patient supine.Torque was applied to the screws with gentle care, but there was no resistance and it was not easy to reach the standard 60 lb (267 n) to 80 lb (356 n).Because a skull fracture was suspected, we canceled the surgery.Emergency head computed tomography showed depressed skull fractures underlying the single-pin sites with an associated epidural hematoma.The fractures and epidural hematoma were treated conservatively, and spontaneous resolution of the hematoma was confirmed.Cervical laminoplasty was performed successfully using a mask-type head holder on the subsequent day.Malfunction ¿ torque was applied to the screws with gentle care, but there was no resistance, and it was not easy to reach the standard 60 lb (267 n) to 80 lb (356 n) torque.Initially, we attributed the lack of torque to the failure of the mayfield skull clamp itself.Another attempt was made with an alternative fixator.To change the insertion point, the left and right sides of the instrument were reversed.Nevertheless, we could not stabilize the skull and obtain appropriate torque.Conclusion: skull fracture and epidural hematoma from use of a mayfield skull clamp are extremely rare complications in adults.However, surgeons must be aware of the risk of these complications in patients with bone fragility or a thin skull.As a precaution for fractures and epidural hematoma in neurosurgical patients with bone fragility or a thin skull, use of a mask-type fixing device or halo ring is recommended.Https://doi.Org/10.1186/s13256-021-02776-8.

Manufacturer Narrative

The mayfield skull 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.The definite root cause cannot be determined but the most probable root cause is when device is not properly positioned, aligned, balanced and put under pressure.The mayfield skull clamp ifus (instructions for use) clearly indicates proper user instructions, the need for biannual inspection and annual preventive maintenance to ensure the proper function of the mayfield to reduce inherent risks.The mayfield skull clamp design was also reviewed and found to meet the astm f3395/f3395m-19 standard specification for neurosurgical head holder devices.No design issues were identified or found to require modification, as a result of this investigation.Additionally, complaint data is monitored for adverse event trends and additional actions as necessary and required.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: UNKNOWN MAYFIELD SKULL CLAMP
• Type of Device: SKULLCLAMPS AND HEADREST SYSTEMS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12602680
• MDR Text Key: 284015034
• Report Number: 3004608878-2021-00591
• 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,Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XXX-MAYFIELD SKULL CLAMP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2021
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Race: Asian