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

Catalog Number A2114

Device Problems Device Inoperable (1663); Component Missing (2306); Device Operates Differently Than Expected (2913)

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

Event Date 11/17/2017

Event Type  malfunction  

Event Description

Originally it was reported that the radiolucent skull clamp needs a repair.Additional request for information was sent and on 28nov2017and 06dec2017, the following was provided: the clamp was very difficult to lock and once placed on patient it would not stay locked.The surgeon refused to use it on the case.Patient was not harmed.On (b)(6) 2017, a (b)(6) -year-old female was to undergo a craniotomy aneurysm clipping.The mayfield skull clamp (lot number unknown) along with the codman adult disposable pins (catalog number a1072), was applied and the patient was placed in a supine position head turned to the right.There was no stereotaxy used.The length of time the product was in use before the event occurred was 10 minutes.The patient was repinned.There was no patient injury or revision/medical intervention required.The action that was taken after the product problem occurred was that the clamp was changed to a non-radiolucent c clamp.Patient was unable to have a cerebral angiogram after the clipping.The patient had to go to the interventional radiology the next day.There was a delay in surgery reported of 10 minutes.Lot number of the skull pins is unknown.Skull pins are not available for evaluation.

Manufacturer Narrative

Integra has completed their internal investigation on december 15, 2017.With respect to the returned unit it has passed all specific functional testing requirements, when unit is properly positioned and put under pressure unit would not have slipped.General maintenance and cleaning required.Device history record reviewed for product id a2114, serial # (b)(4) was manufactured on 08mar15 with 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.This device was previously serviced.The complaint is not confirmed.There were no issues observed.

• Brand Name: MAYFIELD INFINITY XR2 SKULL CLAMP
• Type of Device: MAYFIELD
• 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: 7113717
• MDR Text Key: 95904236
• Report Number: 3004608878-2017-00328
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K090506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2017

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: A2114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 12/15/2017
• Supplement Dates FDA Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2015
• 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: 53 YR