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

Catalog Number	117220000
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hearing Loss (1882); Memory Loss/Impairment (1958); Pain (1994); Loss of Vision (2139)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Revision due to pain.
Additional 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.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: CANCELLOUS BONE SCREW 6.5X20MM
• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY RAYNHAM 1219655; 325 paramount dr; raynham MA 02767 0988
• MDR Report Key: 8167485
• Report Number: 1818910-2018-78329
• Device Sequence Number: 1624530
• Product Code: HWC
• UDI-Device Identifier: 10603295007609
• UDI-Public: 10603295007609
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K970929
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 117220000
• Device Lot Number: EB2GD4000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 01/14/2019; 03/06/2019
• Initial Report FDA Received Date: 12/15/2018
• Supplement Report FDA Received Date: 01/15/2019; 03/28/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention