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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skull Fracture (2077)

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident has been received for evaluation.An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

Springer (2023) published an article titled: "resection of posterior fossa tumors in the semi-sitting position in children younger than 4 years of age." purpose: the semi-sitting position for resection of posterior fossa tumors is a matter of ongoing debate.Here we report about our experience with this approach in children younger than 4 years of age.Methods: we retrospectively analyzed data of children younger than 4 years of age operated on in our institution in the semi-sitting position over a 15-year period.Patients were intraoperatively monitored for venous air embolism (vae) by transthoracic doppler (ttd) or transesophageal echocardiography (tee).The severity of vae was classified according to the tübingen grading scale.Intraoperative incidents of vae were recorded and the patients¿ course was followed postoperatively with a special focus on possible complications.Results: twenty-four children (18 boys, 6 girls) were operated on in the semi-sitting position (26 operations).Mean age was 2.2 years, range between 0.4 and 3.9 years.External ventricular drains were inserted in 18 children with hydrocephalus preoperatively.Vae was detected in 6 instances during surgery (6/26 (23.1%)).In 3 patients with grade 1 vae, no additional treatment was necessary.In one patient with grade 2 vae, intracardiac air suction via the central venous catheter was performed, and in two patients with grade 4 vae, additional cathecholamine-infusion was administered.No major intraoperative complications occurred.Postoperative ct images showed pneumocephalus in all children.In two children, small asymptomatic impression skull fractures at the site of the mayfield pin occurred.Revision surgery was necessary in one child with a suboccipital csf fistula.Adverse event: in our series, there were two depressed but asymptomatic skull fractures caused by the sharp head fixation with the skull fractures caused by the sharp head fixation with the mayfield clamp.Conclusion: the semi-sitting position for resection of tumors in the posterior fossa in children younger than 4 years of age can be safely performed in experienced centers taking special caution to detect and treat potential complications in an interdisciplinary setting.Https://doi.Org/10.1007/s00381-022-05725-y.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d9, g3, g6, h2, h3, h6, h10.Mayfield (unknown catalog#) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The definite root cause of the reported issue could not be determined.Based on the reported complaint, probable root cause is excessive or improper force applied to the patient.No deficiencies with the mayfield product can be confirmed.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• 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: 17194721
• MDR Text Key: 317828122
• Report Number: 3004608878-2023-00119
• 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,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 07/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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