MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY XR2 SKULL CLAMP

Catalog Number A2114

Device Problems Sticking (1597); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/05/2015

Event Type  malfunction  

Event Description

The a2114 skull clamp was applied to the patient and surgery was started.When the surgeon went to flip the patient, the locking mechanism had become stuck in the locked position.While flipping the patient, the adult rocker arm cracked.The broken a2114 clamp was replaced with an a1059 skull clamp.Surgery delay was reported as 30 minutes.There was no patient injury.The a2114 clamp was inspected after the incident.The locking mechanism was now in the unlocked position and was unable to be moved into the locked position.Additional information was requested and the following was received on 25jun2015: on (b)(6) 2015, a (b)(6) male patient underwent a posterior cervical fusion.The patient was initially positioned supine for the surgery and was then repositioned prone.The device was in use for 2 to 4 minutes when the failure occurred after the prone positioning.No stereotaxy equipment was used during the surgery.Patient outcome was reported as no adverse effect.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported information.

Manufacturer Narrative

Integra completed its internal investigation (b)(6) 2015.The investigation included: method: dhr review.Review of complaint management database for similar complaints and service history of the device.Visual inspection.Results: this device was manufactured on 06/16/2011 and a review of the dhr containing serial number (b)(4) showed that this device passed the required inspection points without mrrs, reworks or variances.Service history: date of service: 12/18/2014.Date of service: 10/29/2012.A two year look back for this reported failure and or related to "locking mechanism had become stuck in the locked position or now unlocked can¿t place in locking position" for this product id shows that no additional complaints were received.No new design or manufacturing trends have been identified.Conclusion: pool unit (a2114p 100p) received in good working order, when properly positioned this clamp functions properly.We cannot duplicate a problem with this unit.No crack was observed on the rocker arm of the returned device.

• Brand Name: MAYFIELD INFINITY XR2 SKULL CLAMP
• Type of Device: MAYFIELD
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 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 ; 8006542873
• MDR Report Key: 4890845
• MDR Text Key: 18874494
• Report Number: 3004608878-2015-00181
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A2114
• Device Lot Number: 100P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2011
• 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 Age: 75 YR