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

Catalog Number A1059

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The initial medwatch for this report event was submitted in error under the incorrect facility identifier resulting in mfg report # 9615741-2019-00016.Mfg report # 9615741-2019-00016 has been voided in the system and all further correspondence for this reported event will be found under this mfg report #.This mdr is being submitted as part of service and repair remediation activities associated with capa (b)(4).The device was returned to the manufacturer for service and repair.The unit was cleaned per protocol.It was noted upon inspection that the returned unit did not meet all specific functional tests.Unit received with the plunger stud and cap missing.The lock had both rotational and lateral movement in addition to a residue buildup.New component was added to replace worn internal parts.General maintenance and cleaning were required.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances related to the reported failure.

Event Description

Service and repair of the a1059 mayfield modified skull clamp found the locking mechanism to have both rotational and lateral movement.

• 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: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362319
• MDR Report Key: 9153312
• MDR Text Key: 190525353
• Report Number: 3004608878-2019-01025
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/14/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 10/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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