MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-11-07 for SPF-XL IIB 2/DM N/A 10-1335M manufactured by Ebi, Llc..
[165471076]
Zimmer biomet complaint (b)(4). The event occurred sometime in (b)(6) 2019. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted. The investigation is in progress. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[165471077]
It was reported that the patient was experiencing sharp pain in his lower back. The pain intensified and the patient was unable to move. The patient was admitted to the hospital for three days. The doctors at the hospital told the patient that it was a severe muscle spasm. The patient was given pain medication. The patient was prescribed medications upon release. The patient has followed up with his general practitioner and states that he is in good health and has not had any problems. No additional patient consequences have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2019-00037 |
| MDR Report Key | 9289682 |
| Report Source | CONSUMER |
| Date Received | 2019-11-07 |
| Date of Report | 2019-11-06 |
| Date Mfgr Received | 2019-10-23 |
| Date Added to Maude | 2019-11-07 |
| 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 | SARA DAILEY |
| Manufacturer Street | 399 JEFFERSON ROAD |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9732999300 |
| Manufacturer G1 | EBI, LLC. |
| Manufacturer Street | 399 JEFFERSON ROAD |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPF-XL IIB 2/DM |
| Generic Name | STIMULATOR, INVASIVE BONE GROWTH |
| Product Code | LOE |
| Date Received | 2019-11-07 |
| Model Number | N/A |
| Catalog Number | 10-1335M |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EBI, LLC. |
| Manufacturer Address | 399 JEFFERSON ROAD PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-11-07 |