MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; N/A

Catalog Number A1059

Device Problems Failure To Service (1563); Appropriate Term/Code Not Available (3191)

Patient Problem Laceration(s) (1946)

Event Date 07/31/2015

Event Type  Injury  

Event Description

The patient had two lacerations caused by two mayfield pins on left side of the scalp above the ear, both 3 centimeter long.The incident happened while they were positioning the patient in the prone position for a left c6-c7 foraminotomy and discectomy, when they were about to fix the skull clamp permanently to the base.The operation went ahead as planned except for the half an hour delay when the doctor needed to stitch the lacerations.The patient was alright after the procedure.

Manufacturer Narrative

Integra completed its internal investigation (b)(6) 2015, the investigation included: method: dhr review review of complaint management database for similar complaints.Visual examination results: dhr review for pins involved in this case: device history record reviewed for product id a1072 lot # 1152300 manufactured on june 23, 2015 show no abnormalities related to the reported failure.These pins passed all required inspection points with no associated mrr¿s, variances or rework.No service history.Dhr review for a1059: this device was manufactured on june 30, 2010 and a review of dhrs containing lot code 104 showed that the following lots passed the required inspection points without mrrs or variances.There is no service history for this device.No manufacturing or design related trend has been identified.The returned unit passed all specific functional testing requirements, except for the lock having rotational movement, when unit is properly positioned and put under pressure unit would not have slipped.Upon disassembly repair noted the index knob and the lock will need new components added to replace worn internal parts; this would not have caused a slippage.Conclusion: in summary, the returned unit passed all functional testing requirements, however general maintenance is required as this device was manufactured in 2010 with no prior service history.Lastly, a mayfield patient positioning chart has been provided to the customer as a refresher tool.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: N/A
• 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 45227
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5031719
• MDR Text Key: 24112925
• Report Number: 3004608878-2015-00227
• 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: company representative,foreig
• Reporter Occupation: Other
• Report Date: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• 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: 08/11/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2010
• 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 Outcome(s): Other; Required Intervention