MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-09-27 for EXPEDIUM 6.35 SINGLE INNER SETSCREW 179902000 manufactured by Depuy Raynham.
[2200594]
Contact reported that surgeon noticed on the films of post op surgery 2-weeks out that at least 3 setscrews had visibly loosened. Surgeon scheduled the patient for revision surgery to replace and diagnose the other implants. Upon exploration, surgeon noticed that left side caps were loose and several on the right. He replaced 7 setscrews. As an adverse outcome was reported an mdr is filed to document this event.
Patient Sequence No: 1, Text Type: D, B5
[9328130]
Setscrews were retained by the user facility and not made available. A definitive cause of the event cannot be determined at this time. Care must be taken to ensure that the construct fully tightened and assembled properly. Construct loosening is listed as a possible adverse outcome in the instructions-for-use (ifu) supplied with the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2011-00165 |
| MDR Report Key | 2265883 |
| Report Source | 05,07 |
| Date Received | 2011-09-27 |
| Date of Report | 2011-09-27 |
| Date Mfgr Received | 2011-09-13 |
| Date Added to Maude | 2011-09-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANDREW TOPOULOS |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 027670988 |
| Manufacturer Country | US |
| Manufacturer Postal | 027670988 |
| Manufacturer G1 | DEPUY LELOCLE |
| Manufacturer Street | RUE GIRARDET 29 CASE POSTALE |
| Manufacturer City | LE LOCLE |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXPEDIUM 6.35 SINGLE INNER SETSCREW |
| Generic Name | ORTHOSIS SPONDYLOISTHESIS SPINAL FIXATION |
| Product Code | HNH |
| Date Received | 2011-09-27 |
| Catalog Number | 179902000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY RAYNHAM |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-09-27 |