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

Catalog Number A1059

Device Problems Mechanical Problem (1384); Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Date 09/13/2019

Event Type  Injury  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg report number: 3004608878-2019-01046.

Event Description

This is 1 of 2 reports.A customer reported that the a1059 mayfield modified skull clamp had a slippage.Additional information received from the customer on (b)(6) 2019 that the pressure went from 70 to 20, initial mayfield slipped after pinning and positioning during a craniotomy procedure.The patient was re-pinned and positioned by the physician.The device slipped twice during the first 30 minutes.Revision/medical intervention was required and a staple in the scalp was done to the laceration.There was a delay of 15 to 30 minutes due to the product problem.The only issue as a result of the delay to the patient was the laceration.Current status and outcome of the patient was reported as alive and stable.Disposable pins were used on the procedure however it was not available to be returned for evaluation.A new mayfield was used after the product problem occurred.

Manufacturer Narrative

With respect to the returned unit it has passed all specific functional testing requirements, except for the lock having rotational movement.When unit is not under pressure, this would not have caused a slippage.When unit is properly positioned and put under pressure unit would not have slipped.Unit needed heli-coils added to large starburst threads.Preventative maintenance and cleaning required at this time.The device history record showed no abnormalities related to reported incident nor were there any variances, mrr¿s or reworks associated with this lot/work order number.The reported complaint was not confirmed.Root cause was unknown.The most probable root causes outlined in the risk management file: worn/degraded device (wear and tear).Incorrectly assembled device.Device out of specification calibration.Improperly tested/inspected device.Improper technique used during procedure.Inadequately maintained device used for procedure.Off-label use of device during procedure (user error).Device used with incorrect/unauthorized devices/accessories for procedure.Improper maintenance.Device identifier # (b)(4).

Event Description

N/a.

• 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
• MDR Report Key: 9182550
• MDR Text Key: 168776376
• Report Number: 3004608878-2019-01045
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

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: 179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 11/12/2019
• Supplement Dates FDA Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: A1113 NEUROGEN ADAPTOR; A2009 360 ULTRA POSITIONING
• Patient Age: 61 YR