MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD DISPOSABLE ADULT SKULL PINS (STEEL); ACCESSORIES

Catalog Number A1083

Device Problem Positioning Problem (3009)

Patient Problem Laceration(s) (1946)

Event Date 01/22/2020

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.Linked to mfg report number 3004608878-2020-00145.

Event Description

This is 1 of 2 reports.A medwatch form with uf/ importer report # 2000330000-2020-8006 was received on (b)(6) 2020 with the following information: a (b)(6) year-old female patient sustained a 3-inch laceration during a neurosurgical procedure on the front upper left side of the head from one of the mayfield pins.This occurred while repositioning the patient from supine to prone using the radiolucent mayfield headrest.On (b)(6) 2020, a functionality test was done where the pins and skull clamp were functioning as intended.There was no slippage noted on the phantom head when the clamp was positioned.Additional information received on 05mar2020 stated that the patient had undergone a c5-6 anterior cervical fusion and c3-7 posterior cervical fusion.The mayfield device was repositioned and clamped back on patient.Procedure was completed and device sequestered after for a functional test.The 3- inch laceration was cleaned, stitched and stapled.

Manufacturer Narrative

Udi # (b)(4).The device was not returned for evaluation.The device history record (dhr) showed no abnormalities related to the reported failure.The complaint was unconfirmed.Between 05nov2019 and 30jun2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr 229048 and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period 05nov2019 through 30jun2020.Integra lifesciences contacted (b)(4), director of regulatory programs, office of product evaluation and quality and (b)(4), assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

Event Description

N/a.

• Brand Name: MAYFIELD DISPOSABLE ADULT SKULL PINS (STEEL)
• Type of Device: ACCESSORIES
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 10275575
• MDR Text Key: 203905268
• Report Number: 3004608878-2020-00150
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K932860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2021
• Device Catalogue Number: A1083
• Device Lot Number: W1904076
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: A2003 RADIOLUCENT 2000 BASE SYSTEM
• Patient Age: 52 YR