MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-10-10 for ANCHOR BOLT - LSB STYLE LSBK1-AX-05 manufactured by Ad-tech Medical Instrument Corporation.
[90055525]
As stated in the event description, ad-tech was made aware of an issue via email on (b)(6) 2017. The email stated that an anchor bolt was found to be broken and the end remains in situ in the patient's skull. The bolt was fractured upon removal. The cap was essentially held proximate to the intracranial bolt remnant by the indwelling electrode. Upon removal of the electrode, the cap and proximal end of the anchor bolt were freed. The team opted to leave the bolt fragment in situ as this bolt was in the right occipital region, in the expected surgical field of any resection. The bolt fragment may be retrieved should the patient come to craniotomy. According to the doctor, the patient was restricted to bed for most of 7 days, had exclusively non-convulsive partial seizures, and no apparent trauma or volitional manipulation upon review of video. The product was not sent back to ad-tech for evaluation. Instead, a picture was sent showing the broken bolt. Based on the picture, the alleged deficiency in the complaint was confirmed. This investigation is still on-going.
Patient Sequence No: 1, Text Type: N, H10
[90055526]
Ad-tech received an email from a representative at (b)(6) on (b)(6) 2017 stating that an anchor bolt was found to be broken and the end remains in situ in the patient's skull. The bolt had fractured upon removal. The cap was held proximate to the intracranial bolt remnant by the indwelling electrode. Upon removal of the electrode, the cap and proximal end of the anchor bolt were freed. The team opted to leave the bolt fragment in situ as this bolt was in the right occipital region, in the expected surgical field of any resection. The patient was restricted to bed for most of 7 days and had exclusively non-convulsive partial seizures. According to the customer, there was no apparent trauma or volitional manipulation to the patient upon review of the video.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183456-2017-00009 |
| MDR Report Key | 6936461 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-10-10 |
| Date of Report | 2017-10-09 |
| Date of Event | 2017-08-28 |
| Date Mfgr Received | 2017-09-18 |
| Date Added to Maude | 2017-10-10 |
| 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 | MS. KATHLEEN BARLOW |
| Manufacturer Street | 1901 WILLIAM STREET |
| Manufacturer City | RACINE WI 53404 |
| Manufacturer Country | US |
| Manufacturer Postal | 53404 |
| Manufacturer Phone | 2626341555 |
| Manufacturer G1 | AD-TECH MEDICAL INSTRUMENT CORPORATION |
| Manufacturer Street | 1901 WILLIAM STREET |
| Manufacturer City | RACINE WI 53404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANCHOR BOLT - LSB STYLE |
| Generic Name | ANCHOR BOLT-LSB STYLE |
| Product Code | GCZ |
| Date Received | 2017-10-10 |
| Catalog Number | LSBK1-AX-05 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MEDICAL INSTRUMENT CORPORATION |
| Manufacturer Address | 1901 WILLIAM STREET RACINE WI 53404 US 53404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-10 |