MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES SKULL CLAMP; ¿COMPOSITE SERIES¿

Catalog Number A3059

Device Problem Mechanical Problem (1384)

Patient Problem Laceration(s) (1946)

Event Date 09/10/2019

Event Type  Injury  

Manufacturer Narrative

The device was not yet received by the manufacturer for evaluation.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 they could not fully tighten the adapter to the a3059 mayfield composite series skull clamp during a posterior cervical spine fusion procedure on (b)(6) 2019.Possible cross threading.Was reported.Additional information received on 24sep2019 indicated that the device was in contact with the patient and it caused a skull skin laceration after hey had flipped the patient and while they were trying to position the patient.A 45 minute delay in surgery was noted as they had to change bed, flip the patient back to supine position and back on the new bed in prone position with a different mayfield holder.This resulted in longer operating room (or) time and longer hospitalization.

Event Description

N/a.

Manufacturer Narrative

The device was returned for evaluation.The device history record reviewed with no abnormalities related to the reported failure.Product has passed all specific functional testing requirements, except for the unit was received with a competitor¿s knob that does not work with the mayfield 2 clamp; the lock has up and down movement when unit is unlocked.The complaint was not confirmed.No issues observed.Device identifier # (b)(4).

• Brand Name: MAYFIELD COMPOSITE SERIES SKULL CLAMP
• Type of Device: ¿COMPOSITE SERIES¿
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 9150663
• MDR Text Key: 162354135
• Report Number: 3004608878-2019-01038
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K142238
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OSU JACKSON SPINE TABLE & ADAPTER