MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-24 for ATTUNE SPACER BLOCK 2544-01-014 254401014 manufactured by Depuy Ireland - 9616671.
[184751680]
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.
Patient Sequence No: 1, Text Type: N, H10
[184751682]
It was reported that when setting up instruments for this case it was noticed that one of the basil springs on the spacer block handle was missing.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1818910-2020-08998 |
MDR Report Key | 9871440 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2020-03-24 |
Date of Report | 2020-03-06 |
Date of Event | 2020-03-09 |
Date Mfgr Received | 2020-03-26 |
Device Manufacturer Date | 2015-08-12 |
Date Added to Maude | 2020-03-24 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | KARA DITTY-BOVARD |
Manufacturer Street | 700 ORTHOPAEDIC DR. |
Manufacturer City | WARSAW IN 465810988 |
Manufacturer Country | US |
Manufacturer Postal | 465810988 |
Manufacturer Phone | 6107428552 |
Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
Manufacturer Street | 700 ORTHOPAEDIC DR. |
Manufacturer City | WARSAW IN 465810988 |
Manufacturer Country | US |
Manufacturer Postal Code | 465810988 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ATTUNE SPACER BLOCK |
Generic Name | ATTUNE INSTRUMENTS : SPACER BLOCKS/TRIAL SHIMS |
Product Code | HWT |
Date Received | 2020-03-24 |
Returned To Mfg | 2020-03-26 |
Model Number | 2544-01-014 |
Catalog Number | 254401014 |
Lot Number | BFA109P |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | DEPUY IRELAND - 9616671 |
Manufacturer Address | LOUGHBEG RINGASKIDDY CO. CORK EI |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-24 |