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

Catalog Number A1114

Device Problem Device Slipped (1584)

Patient Problem No Patient Involvement (2645)

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.The device history record review showed no abnormalities related to the reported failure.The reported complaint was not confirmed.The definite root cause could not be reliably determined.Device identifier number: (b)(4).

Event Description

A customer reported that an a1114 mayfield infinity skull clamp unit had slippage but without patient involvement.The date of the incident was unspecified.Additional information had been requested.

• Brand Name: MAYFIELD INFINITY 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: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8754515
• MDR Text Key: 149834626
• Report Number: 3004608878-2019-00148
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K051440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1114
• Device Lot Number: 149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Date Manufacturer Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2014
• 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