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 Laceration(s) (1946)

Event Date 11/04/2019

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.

Event Description

A customer reported that the a1059 mayfield modified skull clamp was used with skull pins and it had slipped, tearing the skin.Additional information received on 08nov2019 indicating that the event occurred right after placement during initial positioning for cervical 6-7 hemilaminectomy procedure on (b)(6) 2019.The patient had to be returned to the supine position to suture the laceration caused by the skull pin slipping.There was minimal delay and no adverse consequence due to the delay.

Manufacturer Narrative

Additional information: d10, g4, g7, h2, h3, h4, h6, h10.Device identifier # (b)(4).The device was returned for evaluation.The device history record (dhr) has been reviewed with no abnormalities related to the reported failure.The device passed all required inspection points with no associated mrr¿s, variances or rework.The reported complaint was not confirmed, no issues were observed.When unit is properly positioned and put under pressure unit would not have slipped.Unit has not had any service since purchased new in 2014.Pm maintenance and cleaning required at this time.The definite root cause cannot be reliably determined.Most probable root causes are: - incorrectly assembled device - improper technique used during procedure - inadequately maintained device used for procedure.

• 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: 9378819
• MDR Text Key: 168429536
• Report Number: 3004608878-2019-01106
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SKULL PINS.