MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-20 for 4.5MM PERIPHERAL SCREW - 24MM 5572-4524 manufactured by Stryker Gmbh.
[188636189]
Upon completion of investigation, additional information will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[188636190]
As reported: "patient received a primary rsa on (b)(6) 2016, with no issues. Patient came back and had a shoulder scope on (b)(6) 2019, which presented what appeared to be visible metallosis. Patient then came back on (b)(6) 2019 to have his rsa removed and have a shoulder spacer implanted. " additionally reported: "tissue was sent to the lab and metallosis, as well as p acnes were confirmed. Patient currently an antibiotic spacer implanted with gent/vanc cement around the head/neck junction. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2020-00774 |
| MDR Report Key | 9862618 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-12-20 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-20 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KEVIN SMITH |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4.5MM PERIPHERAL SCREW - 24MM |
| Generic Name | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED |
| Product Code | KWS |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-01-29 |
| Model Number | 5572-4524 |
| Catalog Number | 5572-4524 |
| Lot Number | 662N5R |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER GMBH |
| Manufacturer Address | BOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-20 |