MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 DXTEND SCREW LOCK D4.5X24MM; DELTA XTEND IMPLANTS : SCREWS

Catalog Number 130790024

Device Problem Failure to Osseointegrate (1863)

Patient Problems Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Patient was revised to address loosening of the glenoid and screws component at bone to implant interface.The glenoid and screws were found to not be stable, and the patient was revised intraoperatively to a revision glenoid.

Manufacturer Narrative

(b)(4).No device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DXTEND SCREW LOCK D4.5X24MM
• Type of Device: DELTA XTEND IMPLANTS : SCREWS
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; b.p. 256; leeds LS118 DT; UK LS118DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 8182043
• MDR Text Key: 130971541
• Report Number: 1818910-2018-78785
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027836
• UDI-Public: 10603295027836
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 130790024
• Device Lot Number: 5326261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR