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

Catalog Number A1114

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This is the first of four reports (same problem, same patient, same user facility, different product id's for the mayfield system).Linked to mfg reports: 3004608878-2017-00004, 3004608878-2017-00005, 3004608878-2017-00006.The patient was fixed to the mayfield system and during the procedure it moved above 2 cm.The surgeon held the head of patient so it did not move further down.It did not move any further than 2 cm and the surgery was completed.They mayfield system included product id as follows: a1114 mayfield infinity skull clamp, a1113 mayfield neurogen adaptor, a1018 mayfield swivel adaptor and a2101 mayfield ultra base unit.Additional information has been requested.

Manufacturer Narrative

Integra has completed their internal investigation on 01/19/2017.The investigation included: methods: evaluation of actual device, review of device history records, review of complaints history.Results: the system was setup with all these components a1113 mayfield neurogen adaptor (new) sn: (b)(4), a1114 mayfield clamp cranien sn: (b)(4), a1018 swivel adaptor sn: (b)(4), a2101 ultra base unit sn: (b)(4).While testing some weight was applied to the skull clamp, the movement reported by customer was observed; the base unit moved slightly down wards.After this the base unit strength was tested with force gauge.The base unit began to move at about 23lbf.Evaluation of the additional devices: the swivel adaptor works fine only the label is worn.At the crossbar adaptor one screw is bending.The skull clamp locking mechanism is slightly out of our specifications.All devices are first time in service.Device history record reviewed for this product id work order / lot/ serial # (b)(4) a total of (b)(4) pcs were manufactured on 11/15/2014 show no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points with no associated mrr¿s, variances or rework.No service history is on file for this device.No manufacturing or design related trend has been identified.Conclusion: the root cause was determined to be failure of the a2101(mayfield ultra base unit) component due to its condition and adjustment at the time of surgery.This unit should not have been used in surgery with the improper adjustment condition that it was in at the time of this incident.

• Brand Name: MAYFIELD INFINITY 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6223612
• MDR Text Key: 64184901
• Report Number: 3004608878-2017-00003
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K051440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2016
• Initial Date FDA Received: 01/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2014
• 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