FDA Adverse Event
Other
Summary report: N
RHBMP
MDR report key: 1374406
·
Received May 4, 2009
Report
- Report Number
- 1224732-2009-00023
- Event Type
- Other
- Date Received
- May 4, 2009
- Report Date
- April 15, 2009
- Manufacturer
- STRYKER BIOTECH
- Product Code
- MPY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON (B)(6) 2009, A STRYKER SPINE REP RECEIVED A REPORT OF A POSSIBLE ADVERSE EVENT FROM A PHYSICIAN IN (B)(6). THE PHYSICIAN REPORTED THAT A PT DEVELOPED HYPERSENSITIVITY TO TOUCH IN UNSPECIFIED LOCATION(S), APPROX 6 MONTHS AFTER RECEIVING AN OP-1 CONTAINING PRODUCT. THE PHYSICIAN REPORTED TO THE SPINE REP THAT THE PT IS NOW HYPERSENSITIVE TO TOUCH IN AREAS WHERE SHE HAD NOT BEEN BEFORE. THE PHYSICIAN STATED THAT HE SUSPECTS THE HYPERSENSITIVITY MAY BE THE RESULT OF AN AUTOIMMUNE RESPONSE, BUT HE DID NOT ELABORATE. NO ADD'L DETAILS WERE PROVIDED. ADD'L INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RHBMP | IMPLANT | MPY | STRYKER BIOTECH | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |