MAUDE Adverse Event Report: DEPUY RAYNHAM 1219655 CANCELLOUS BONE SCREW 6.5X20MM; BONE SCREWS AND PINS : SCREWS

Catalog Number 117220000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hearing Loss (1882); Memory Loss/Impairment (1958); Pain (1994); Loss of Vision (2139)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Revision due to pain.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).

• Brand Name: CANCELLOUS BONE SCREW 6.5X20MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY RAYNHAM 1219655; 325 paramount dr; raynham MA 02767 0988
• Manufacturer (Section G): JTE RAYNHAM MFG SITE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 8167485
• MDR Text Key: 130460251
• Report Number: 1818910-2018-78329
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10603295007609
• UDI-Public: 10603295007609
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K970929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2018

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: 117220000
• Device Lot Number: EB2GD4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/15/2018
• Supplement Dates Manufacturer Received: 01/14/2019; 03/06/2019
• Supplement Dates FDA Received: 01/15/2019; 03/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention