MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-09 for SPF SPINAL FUSION STIMULATOR N/A 10-1335M manufactured by Biomet Spine - Broomfield.
[28347023]
The biomet spine implantable spinal fusion stimulators physician? S manual & full prescribing information for spf plusmini, spf - xl iib establishes the following? Handling? Instructions in the? Precautions? :? Do not disconnect the leads from the cathodes during the surgical procedure.? Different from what is instructed in handling precaution notice of the biomet spine spf physician? S manual, the surgeon utilized a minimally invasive surgical technique which requires the detachment and disconnection of the lead/cathode connectors pre-operatively or prior to implantation to permit him to pull the lead and cathode apart; thus, allowing passage one of those under the patient? S skin line before reattaching it. Even though, the physician didn? T follow the corresponding product ifu rendering the product inoperable for use, the unfavorable event of disengagement of the dbs cable from the connector could also occur during explantation. Based on the results of evaluation the disengagement of the dbs cable from the male pin connector crimp is most likely caused by the overlap of the actual pull force yield of this connection (9. 3 to 18 pounds) and the male pin-female socket connection (2. 5 to 13. 3 pounds). This overlapping issue was also aggravated by an apparent inadequate crimping equipment adjustment which in turn caused an increase in the overlapping range between both connections. The risk of having the dbs cable disengaged from the male pin connector crimp during the implantable stimulator explantation procedures is not significant as at this stage since therapeutic treatment has already completed and that the male pin connector will remain covered by the pin sleeve, thus preventing direct contact of the titanium pin with human tissue. The patient would have completed their therapeutic treatment as intended and there would be no adverse effect during subsequent mri testing post-explantation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[28347024]
The sales associate reported that for the past three years, pre-operatively the surgeon disconnects the cathodes from their corresponding unit leads in order to conduct stimulator implantation using a minimal invasive mis procedure. During a procedure on (b)(6), 2015 the cable of the stimulator disengaged (separated) from the male pin connector crimp joint and therefore was unable to be used in the surgery. No adverse events were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004485144-2015-00061 |
| MDR Report Key | 5140335 |
| Date Received | 2015-10-09 |
| Date of Report | 2015-09-10 |
| Date of Event | 2015-05-05 |
| Date Mfgr Received | 2015-09-10 |
| Device Manufacturer Date | 2015-02-06 |
| Date Added to Maude | 2015-10-09 |
| 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 | MRS. MICHELLE COLE |
| Manufacturer Street | 310 INTERLOCKEN PARKWAY SUITE 120 |
| Manufacturer City | BROOMFIELD CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal | 80021 |
| Manufacturer Phone | 3034437500 |
| Manufacturer G1 | BIOMET SPINE - BROOMFIELD |
| Manufacturer Street | 310 INTERLOCKEN PARKWAY SUITE 120 |
| Manufacturer City | BROOMFIELD CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SPF SPINAL FUSION STIMULATOR |
| Generic Name | IMPLANTABLE STIMULATOR |
| Product Code | LOE |
| Date Received | 2015-10-09 |
| Returned To Mfg | 2015-05-27 |
| Model Number | N/A |
| Catalog Number | 10-1335M |
| Lot Number | 222550 |
| ID Number | SEE H10 |
| Device Expiration Date | 2016-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET SPINE - BROOMFIELD |
| Manufacturer Address | 310 INTERLOCKEN PARKWAY SUITE 120 BROOMFIELD CO 80021 US 80021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-09 |