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

Catalog Number A3059

Device Problem Device Slipped (1584)

Patient Problem Injury (2348)

Event Date 10/25/2019

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 sales representative reported on behalf of the customer of a slippage with the a3059 mayfield composite series skull clamp.Additional information received on 11nov2019 indicating that the event occurred on (b)(6) 2019.There was a 90 minute surgery delay.There was no patient injury reported.However, the patient was flipped back over to supine, repinned with a new clamp, flipped again and repositioned.

Event Description

N/a.

Manufacturer Narrative

Device identifier (b)(4).The device was not returned for evaluation.The device history record was reviewed with no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points with no associated mrr¿s, variances or rework.The reported complaint was not confirmed as no unit has returned for evaluation.The definite root cause cannot be reliably determined.Most probable root causes are outlined in the risk management file incorrectly assembled device.Improper technique used during procedure.Inadequately maintained device used for procedure.

• 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: 9347536
• MDR Text Key: 167175840
• Report Number: 3004608878-2019-01098
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• 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?: No
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1