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

Catalog Number A1059

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The patient was in prone position and when the surgeon applied pressure to implant the screws, the patients head flexed forward in the pins/clamp.The patient's head did not come out of the pins or slip.There was no injury to the patient and the doctor proceeded to finish the case with the same clamp.Additional information has been requested.

Manufacturer Narrative

Additional information received from the customer on (b)(6) 2016: the event occurred within the last 2 weeks of (b)(6).The patient's gender was unknown and age was greater than 50 years.The patient was undergoing a post cervical fusion and a stereotaxy device was not used.The skull clamp was in use for 45 minutes prior to the product problem occurring.A1072 mayfield adult disposable skull pins were also in use.There was no harm to the patient and the case was finished.

Manufacturer Narrative

Integra has completed their internal investigation on 10 may 2016.The investigation included: methods: evaluation of actual device, review of device history records, review of complaint history, results: evaluation of device: the reported complaint was not confirmed - no issues observed.Unit cleaned per protocol 1907.With respect to the returned unit it has passed all specific functional testing requirements, except for the lock having rotational movement, this would not have caused a slippage; when unit is properly positioned and put under pressure unit would not have slipped.The plunger stud will not function properly from the roll pin is coming out of the base, this would not have caused slippage and was reported, happened after the surgery the dhr review has been deemed satisfactory.Device history record reviewed for this product id lot code 099 show no abnormalities related to the reported failure.This device passed all required inspection points with no associated mrr¿s, variances or rework.No trend has been identified.Conclusion: in summary we are unable to confirm or duplicate the end users experience.The returned unit passed all functional testing requirements, however general maintenance is required as this device was manufactured in 2009 with no prior service history.

• Brand Name: MAYFIELD MODIFIED 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: 5350230
• MDR Text Key: 35681447
• Report Number: 3004608878-2016-00002
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: PREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2015

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: A1059
• Device Lot Number: 099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2015
• Initial Date FDA Received: 01/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/01/2016; 05/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2009
• 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