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); Unintended Movement (3026)

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

Event Date 12/28/2016

Event Type  malfunction  

Event Description

On (b)(6) 2016, the a1059 mayfield modified skull clamp was in use on a (b)(6) female patient undergoing a tumor removal in the posterior cranial fossa when movement was detected.The issue was detected during surgery.The patient was in a ventral decubitus position.There was no injury to the patient, however, the event led to an increase of surgery time of 15 minutes to reposition the patient.The 15 minutes increase did not have any adverse consequences to the patient.

Manufacturer Narrative

Integra has completed their internal investigation on 02/07/2017.The investigation included: methods: evaluation of actual device, review of device history records, review of complaints history.Results: during evaluation the following was observed: evaluation verified customer information as valid.Swivel base has movement.A1059 mayfield modified skull clamp sn: (b)(4) lot 159.Device first time in service.Device history record reviewed for this product id work order / lot/ serial # (b)(4) /159.A total of (b)(4) pcs were manufactured on 10/16/2015, 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 "movement " for this product id shows that 6 complaints were received including this case, see below.No new design or manufacturing trends have been identified.This issue will be monitored.Conclusion: the root cause for this failure was determined to be heavy use and wear and tear in field conditions.

• 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: 6277442
• MDR Text Key: 66039581
• Report Number: 3004608878-2017-00020
• 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: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• 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: 015674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2015
• 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: 60 YR