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

Catalog Number A1059

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913); Device Unsafe to Use in Environment (2918)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The doctor refused to use a rental a1059 mayfield modified skull clamp.The doctor stated that it was unsafe to use and the lock on the rotator arm was loose and totally unsafe.He would not use it on a patient so it did not come into contact with patient.There was too much movement with the entire clamp.There was not report of injury or delay in surgery.

Manufacturer Narrative

Integra has completed their internal investigation on (b)(6) 2017.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: engineering and repairs were able to verify the customer complaint.The unit was taken apart by the repairs department and it was found that the set screw was loose inside the assembly.The root cause is not yet determined; however this failure mode will be tracked and evaluated for trends.Device history record reviewed for this product id work order / lot/ serial # 096392/ 124 a total of 25 pcs were manufactured on (b)(6) 2012 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.A two year lookback in trackwise for this reported failure and or related to "locking mechanism too loose¿ for this product id shows that 5 complaints were received including this case.Conclusion: engineering and repairs were able to verify the customer complaint.The unit was taken apart by the repairs department and it was found that the set screw was loose inside the assembly.The root cause is not yet determined; however this failure mode will be tracked and evaluated for trends.

• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6219754
• MDR Text Key: 64047077
• Report Number: 3004608878-2017-00002
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2016

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: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 01/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• 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