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

Catalog Number A1059

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 07/27/2020

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.Linked to mfg report numbers 3004608878-2020-00515, 3004608878-2020-00516, and 3004608878-2020-00517.

Event Description

This is 1 or 4 reports.A medwatch form with uf/ importer report (b)(4) was received on 13aug2020 with the following information: a (b)(6) male patient suffered a scalp laceration as a result of the a1059 mayfield modified skull clamp.Additional information received on 14aug2020 indicated that the patient undergone a stereotactic brain biopsy on (b)(6) 2020.The patient was initially positioned supine and was not repositioned during surgery.The patient suffered scalp laceration (unspecified); compression was applied.The patient was doing fine after the procedure.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).The mayfield skull clamp was returned for evaluation.Device history record (dhr) - the dhr shows no abnormalities related to the reported failure.The reported complaint was not confirmed from the evaluation of the returned product.The reported failure could not be duplicated.No issues observed from the functional testing of the device.When unit is properly positioned and put under pressure unit would not have slipped.The observed condition is likely caused by improperly handling of the device.The definite root cause cannot be reliably determined.

Event Description

N/a.

• 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: 10513445
• MDR Text Key: 206295633
• Report Number: 3004608878-2020-00514
• 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: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 10/29/2020
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR