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

Catalog Number A1059

Device Problems Device Slipped (1584); Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 02/02/2016

Event Type  Injury  

Event Description

Patient slipped during a posterior cervical procedure.Patient sustained minor laceration.Additional information has been requested.

Manufacturer Narrative

Additional information received on 30mar2016 with the following: on (b)(6) 2016, the patient (age unknown) was positioned prone for a posterior cervical procedure.The patient was not repositioned at any time during the surgery.Sixty pounds of pressure was applied.The surgery was not performed with a stereotaxy device.Post surgery, the surgeon noticed the laceration on the patient's head on the single pin side of the skull clamp.The 2cm laceration required staples.Integra has completed their internal investigation on 29mar2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: 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 the unit is properly positioned and put under pressure, the unit would not have slipped.The unit needs to be machined to have heli-coils added to large starburst threads; general maintenance and cleaning required.Device history record reviewed for this product id work order and lot # 00593/139 manufactured on october 25, 2013 show no abnormalities related to the reported failure.This device 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.In summary, the end user's experience could not be confirmed or duplicated.The returned unit passed all functional testing requirements, however general maintenance is required as this device was manufactured in 2013 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5464005
• MDR Text Key: 39197088
• Report Number: 3004608878-2016-00040
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/03/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Device Lot Number: 00593/139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2016
• Initial Date FDA Received: 02/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2013
• 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