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

Catalog Number A1059

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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.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.No service history on file.The reported complaint was not confirmed.Root cause was unknown.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.

Event Description

A sales representative reported that the a1059 mayfield modified skull clamp had a suspected slippage but there was no patient injury.Additional information has been requested.

• 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: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362319
• MDR Report Key: 9213076
• MDR Text Key: 189725343
• Report Number: 3004608878-2019-01056
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• 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: 171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Date Manufacturer Received: 09/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2017
• 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